Medical spa. It sounds so soothing. It evokes images of candles, beautiful music, warmth and pampering. Spahhhh! The words alone can make one relax.

Medical spas are marketing vehicles for medical procedures. If they are offering medical procedures, they must be owned by physicians. The use of the term "medical spa" is for advertising purposes to make the procedures seem more appealing. In reality, however, it is the practice of medicine.

There is no harm in seeking pampering or in wanting to look better. A visit to a spa may provide a needed respite from our stressful lives, and treatments that make us look better often make us feel better. The Medical Board, however, is concerned when medicine is being marketed like a pedicure, and consumers are led to believe that being injected, lasered, and resurfaced requires no more thought than changing hair color.

Medical treatments should be performed by medical professionals only. There is risk to any procedure, however minor, and consumers should be aware of those risks. While it is illegal for unlicensed personnel to provide these types of treatments, consumers should be aware that some persons and firms are operating illegally. Cosmetologists, while licensed professionals and highly qualified in superficial treatments such as facials and microdermabrasion, may never inject the skin, use lasers, or perform medical-level dermabrasion or skin peels. Those types of treatments must be performed by qualified medical personnel. In California, that means a physician, or a registered nurse or physician assistant under the supervision of a physician.

Patients must know the qualifications of persons to whom they are entrusting their health. Those seeking cosmetic procedures should know that the person performing them is medically qualified and experienced. Specifically, patients should:

Know who will perform the procedure and his or her licensing status: If a physician is performing the treatment, you should ask about his or her qualifications. Is the doctor a specialist in these procedures? Is he or she board certified in an appropriate specialty? Licensing status may be verified at the board's Web site at www.mbc.ca.gov., "Check Your Doctor Online." Board certification status may be verified at www.abms.org.

If a registered nurse or physician assistant will be doing the procedure, what are his or her qualifications? Where is the doctor who is supervising them? Are they really being supervised, or are they acting alone with a paper-only supervisor? (Although the physician does not have to be onsite, he or she must be immediately reachable.) Again, you should check the supervising doctor's credentials, as well as the nurse or physician assistant. Those Web sites are www.rn.ca.gov and www.physicianassistant.ca.gov.

Be fully informed of about the risks: All procedures carry risks, and conscientious practitioners will fully disclose them. Medical professionals have an ethical responsibility to be realistic with their patients and tell them what they need to know. Use caution if procedures are being heavily marketed, with high-pressure sales techniques promising unrealistic results.

Observe the facility and its personnel: Medical procedures should be done in a clean environment. While one cannot see germs, one can see if the facility looks clean and personnel wash their hands, use gloves, and use sound hygienic practices.

Ask about complications, and who is available to handle them: If you should have an adverse reaction, you want to know who will be there to help. Who should you call, and what hospital or facility is available where the physician can see you? Qualified physicians have facilities or privileges at a hospital where they can handle emergencies.

Don't be swayed by advertisements and promises of low prices: There are a host of medical professionals offering competent, safe cosmetic procedures. If they are being offered at extremely low prices, there is a good possibility that what they are advertising is not what will be delivered. Genuine Botox, Collagen, Restalyne, and other injections are expensive. If someone is offering an injection for $50, when the going rate at a physician's office is $500, then you can be sure it's not the real McCoy. There have been tragic cases of unscrupulous practitioners injecting industrial silicone and toxic counterfeit drugs that have made patients critically ill, caused disfigurement, or resulted in death.

Know that there is a substantial financial cost to obtaining qualified treatments, as well as some risk. If you want the best results, do your homework and only trust those who demonstrate competence and caution.

The following is to provide guidance to physicians on the prohibition against the corporate practice of medicine.

Note: This area of law can be complicated, therefore physicians are encouraged to discuss their medical practices and business enterprises with appropriately knowledgeable legal experts. The Medical Board of California continues to receive complaints and inquiries about the law, and some repeating issues are presented here.

The Medical Practice Act, Business and Professions Code section 2052, provides: "Any person who practices or attempts to practice, or who holds himself or herself out as practicing...[medicine] without having at the time of so doing a valid, unrevoked, or unsuspended certificate...is guilty of a public offense."

Business and Professions Code section 2400, within the Medical Practice Act, provides in pertinent part:

"Corporations and other artificial entities shall have no professional rights, privileges, or powers."

The policy expressed in Business and Professions Code section 2400 against the corporate practice of medicine is intended to prevent unlicensed persons from interfering with or influencing the physician's professional judgment. The decisions described below are examples of some of the types of behaviors and subtle controls that the corporate practice doctrine is intended to prevent. From the Medical Board's perspective, the following healthcare decisions should be made by a physician licensed in the State of California and would constitute the unlicensed practice of medicine if performed by an unlicensed person:

Determining what diagnostic tests are appropriate for a particular condition.

Determining the need for referrals to, or consultation with, another physician/specialist.

Responsibility for the ultimate overall care of the patient, including treatment options available to the patient.

Determining how many patients a physician must see in a given period of time or how many hours a physician must work.

In addition, the following "business" or "management" decisions and activities, resulting in control over the physician's practice of medicine, should be made by a licensed California physician and not by an unlicensed person or entity:

Ownership is an indicator of control of a patient's medical records, including determining the contents thereof, and should be retained by a California-licensed physician.

Selection, hiring/firing (as it relates to clinical competency or proficiency) of physicians, allied health staff and medical assistants.

Setting the parameters under which the physician will enter into contractual relationships with third-party payers.

Decisions regarding coding and billing procedures for patient care services.

Approving of the selection of medical equipment and medical supplies for the medical practice.

The types of decisions and activities described above cannot be delegated to an unlicensed person, including (for example) management service organizations. While a physician may consult with unlicensed persons in making the "business" or "management" decisions described above, the physician must retain the ultimate responsibility for, or approval of, those decisions.

The following types of medical practice ownership and operating structures also are prohibited:

Non-physicians operating in a business for which physician ownership and operation are required: any business advertising, offering, and/or providing patient evaluation, diagnosis, care and/or treatment. These are services which can only be offered or provided by physicians.

Physician(s) operating a medical practice as a limited liability company, a limited liability partnership, or a general corporation. Management Service Organizations arranging for, advertising, or providing medical services rather than only providing administrative staff and services for a physician's medical practice (non-physician exercising controls over a physician's medical practice, even where physicians own and operate the business).

A physician acting as "medical director" when the physician does not own the practice. For example, a business offering spa treatments that include medical procedures such as Botox injections, laser hair removal, and medical microdermabrasion, that contracts with or hires a physician as its "medical director."

In the examples above, non-physicians would be involved in the unlicensed practice of medicine, and the physician may be aiding and abetting the unlicensed practice of medicine.

Due to an ongoing influx of calls to the board regarding who may perform what type of medical/cosmetic procedure and where, the following frequently asked questions and responses are provided for informational purposes and as a reminder. This is a reprint and update to an article published in the October 2002 Action Report.

Who may use lasers or intense pulse light devices to remove hair, spider veins and tattoos?

Physicians may use lasers or intense pulse light devices. In addition, physician assistants and registered nurses (not licensed vocational nurses) may perform these treatments under a physician's supervision. Unlicensed medical assistants, licensed vocational nurses, cosmetologists, electrologists, or estheticians may not legally perform these treatments under any circumstance, nor may registered nurses or physician assistants perform them independently, without supervision.

Who may inject Botox?

Physicians may inject Botox, or they may direct registered nurses, licensed vocational nurses, or physician assistants to perform the injection under their supervision. No unlicensed persons, such as medical assistants, may inject Botox.

I've been approached by a nurse to be her "sponsoring physician" for her laser and Botox practice; would that be legal? No. There is no such thing as a "sponsoring physician." Nurses may not, under California law, employ or contract with a physician for supervision. A nurse may not have a private practice with no actual supervision. While the laws governing nursing recognize "the existence of overlapping functions between physicians and registered nurses" and permit "additional sharing of functions within organized health care systems that provide for collaboration between physicians and registered nurses" (Business and Professions Code section 2725), nurses only may perform medical functions under "standardized procedures." The board does not believe this allows a nurse to have a private medical cosmetic practice without any physician supervision.

I've been asked by a layperson to serve as "medical director" for a "medi-spa" that provides laser and other cosmetic medical services; would that be legal?

No. No one who cannot legally practice medicine can offer or provide medical services (Business and Professions Code section 2052). A physician contracting with or acting as an employee of a lay-owned business would be aiding and abetting the unlicensed practice of medicine (Business and Professions Code section 2264, 2286, and 2400). To offer or provide these services, the business must be a physician-owned medical practice or professional medical corporation with a physician being the majority shareholder.

I see these ads for "Botox Parties" and think that it has to be illegal. Is it?

The law does not restrict where Botox treatments may be performed, as long as they are performed by a physician or by a registered nurse, licensed vocational nurses, or physician assistant under a physician's supervision.

Who may perform microdermabrasion?

It depends. If it's a cosmetic treatment, that is to say it only affects the outermost layer of the skin or the stratum corneum, then a licensed cosmetician or esthetician may perform the treatment. If it's a medical treatment, that is to say it penetrates to deeper levels of the epidermis, then it must be performed by a physician, or by a registered nurse or physician assistant under supervision. Treatments to remove scarring, blemishes, or wrinkles would be considered a medical treatment. Unlicensed personnel, including medical assistants, may not perform any type of microdermabrasion.

I would like to provide non-medical dermabrasion, and hire an esthetician to perform that and also cosmetic facial and skin treatments. What do I need to do?

It is legal for physicians to hire licensed cosmetologists or estheticians to perform cosmetology services, if they have obtained a facility permit from the Bureau of Barbering and Cosmetology. You may apply for a permit with the Department of Consumer Affairs, Bureau of Barbering and Cosmetology, 2420 Del Paso Blvd., Sacramento, CA 95834. You may obtain application forms at the DCA Web site at www.dca.ca.gov. All licensed cosmetologists, including estheticians, must perform their services in a facility with a permit.

Why can't I use a medical assistant instead of a nurse?

Medical assistants are not licensed professionals. While doctors have become accustomed to their assistance in medical office practices, they are not required to have any degree, nor do they have to pass an examination or be licensed. For that reason, the law only allows them to perform technical supportive services as described in sections 2069-2071 of the Business and Professions Code, and Title 16, California Code of Regulations, sections 1366-1366.4.

What is the penalty if I get caught using or helping an unlicensed person to perform medical treatment?

The law provides a number of sanctions, ranging from license discipline to criminal prosecution, for aiding and abetting the unlicensed practice of medicine. Physicians could be charged with aiding and abetting unlicensed practice, and the employee could be charged with unlicensed practice.

I understand that all of these practices may be illegal, but I see advertisements all the time for these kinds of illegal practices. What should I do?

You may file a complaint with the Medical Board. To do so, please send the advertisement, the publication name and date, and your address and telephone number where you may be reached for further information, to our Central Complaint Unit at 1426 Howe Avenue, Suite 54, Sacramento, CA 95825. The board will contact the business, inform them of the law, and direct them to cease any illegal practice. If it is simply the advertisement that is misleading, they will be directed to change or clarify the ad.

2051. The physician's and surgeon's certificate authorizes the holder to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions.

2052. (a) Notwithstanding Section 146, any person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person, without having at the time of so doing a valid, unrevoked, or unsuspended certificate as provided in this chapter or without being authorized to perform the act pursuant to a certificate obtained in accordance with some other provision of law is guilty of a public offense, punishable by a fine not exceeding ten thousand dollars ($10,000), by imprisonment in the state prison, by imprisonment in a county jail not exceeding one year, or by both the fine and either imprisonment.

2053.5. (a) Notwithstanding any other provision of law, a person who complies with the requirements of Section 2053.6 shall not be in violation of Section 2051 or 2052 unless that person does any of the following:

(1) Conducts surgery or any other procedure on another person that punctures the skin or harmfully invades the body. (2) Administers or prescribes X-ray radiation to another person.

(3) Prescribes or administers legend drugs or controlled substances to another person.

(4) Recommends the discontinuance of legend drugs or controlled substances prescribed by an appropriately licensed practitioner.

(5) Willfully diagnoses and treats a physical or mental condition of any person under circumstances or conditions that cause or create a risk of great bodily harm, serious physical or mental illness, or death.

(6) Sets fractures.

(7) Treats lacerations or abrasions through electrotherapy.

(8) Holds out, states, indicates, advertises, or implies to a client or prospective client that he or she is a physician, a surgeon, or a physician and surgeon.

(b) A person who advertises any services that are not unlawful under Section 2051 or 2052 pursuant to subdivision (a) shall disclose in the advertisement that he or she is not licensed by the state as a healing arts practitioner.

2053.6. (a) A person who provides services pursuant to Section 2053.5 that are not unlawful under Section 2051 or 2052 shall, prior to providing those services, do the following:

(1) Disclose to the client in a written statement using plain language the following information:

(A) That he or she is not a licensed physician.

(B) That the treatment is alternative or complementary to healing arts services licensed by the state.

(C) That the services to be provided are not licensed by the state.

(D) The nature of the services to be provided.

(E) The theory of treatment upon which the services are based. (F) His or her educational, training, experience, and other qualifications regarding the services to be provided.

(2) Obtain a written acknowledgment from the client stating that he or she has been provided with the information described in paragraph (1). The client shall be provided with a copy of the written acknowledgement, which shall be maintained by the person providing the service for three years.

(b) The information required by subdivision (a) shall be provided in a language that the client understands.

(c) 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.

2234. The Division of Medical Quality shall take action against any licensee who is charged with unprofessional conduct. In addition to other provisions of this article, unprofessional conduct includes, but is not limited to, the following:

(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the violation of, or conspiring to violate any provision of this chapter.

(b) Gross negligence.

(c) Repeated negligent acts. To be repeated, there must be two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.

(1) An initial negligent diagnosis followed by an act or omission medically appropriate for that negligent diagnosis of the patient shall constitute a single negligent act.

(2) When the standard of care requires a change in the diagnosis, act, or omission that constitutes the negligent act described in paragraph (1), including, but not limited to, a reevaluation of the diagnosis or a change in treatment, and the licensee's conduct departs from the applicable standard of care, each departure constitutes a separate and distinct breach of the standard of care.

(d) Incompetence.

(e) The commission of any act involving dishonesty or corruption which is substantially related to the qualifications, functions, or duties of a physician and surgeon.

(f) Any action or conduct which would have warranted the denial of a certificate.

(g) The practice of medicine from this state into another state or country without meeting the legal requirements of that state or country for the practice of medicine. Section 2314 shall not apply to this subdivision. This subdivision shall become operative upon the implementation of the proposed registration program described in Section 2052.5.

2234.1. (a) A physician and surgeon shall not be subject to discipline pursuant to subdivision (b), (c), or (d) of Section 2234 solely on the basis that the treatment or advice he or she rendered to a patient is alternative or complementary medicine, including the treatment of persistent Lyme Disease, if that treatment or advice meets all of the following requirements:

(1) It is provided after informed consent and a good-faith prior examination of the patient, and medical indication exists for the treatment or advice, or it is provided for health or well-being.

(2) It is provided after the physician and surgeon has given the patient information concerning conventional treatment and describing the education, experience, and credentials of the physician and surgeon related to the alternative or complementary medicine that he or she practices.

(3) In the case of alternative or complementary medicine, it does not cause a delay in, or discourage traditional diagnosis of, a condition of the patient.

(4) It does not cause death or serious bodily injury to the patient.

(b) For purposes of this section, "alternative or complementary medicine," means those health care methods of diagnosis, treatment, or healing that are not generally used but that provide a reasonable potential for therapeutic gain in a patient's medical condition that is not outweighed by the risk of the health care method.

(c) Since the National Institute of Medicine has reported that it can take up to 17 years for a new best practice to reach the average physician and surgeon, it is prudent to give attention to new developments not only in general medical care but in the actual treatment of specific diseases, particularly those that are not yet broadly recognized in California.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Complete Harmony is a range of 20 Flower Formulas which follow the principles of Vibrational medicine, Chinese acupuncture, the Chakra system, colour and the philosophy of emotional trauma. These Phytobiophysics® Flower Formulas have the capacity to stabilise and harmonise the deep trauma, which occur in modern society on all levels of consciousness.

Her more advanced research has led to the creation of the Superfit range, these are powerful Tree Formulas which support on a deep spiritual level and enable healing and recovery on a deep level.

The Institute of Phytobiophysics® was established in 1990 and was affiliated to the Open International University of Complementary medicine in 1992. The Institute offers comprehensive formal Post graduate training to practitioners of all medical modalities. The Institute syllabus was accredited by the Guild of Professional Practitioners in 1997 and was affiliated to The Complementary Medical Association in 1999. The Institute now offers a two year post graduate Diploma course offered in modules.

For further information of the charter of The Open International University of Complementary Medicine [Medicina Alternativa] please read the Training prospectus .

There are now approximately 7000 practitioners world wide practising the Mossop Philosophy and using the Phytobiophysics® formulas.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Plenary Session III: CAM Credentialing and Licensure

MR. COHEN: Thank you. Distinguished Commissioners, I would like to present five key ideas concerning licensure and complementary and alternative medicine and conclude with some thoughts on the future directions for regulatory authority.

Let's go back in history. During colonial times, the state neither provided nor required health care licensure so anybody could practice treating the sick, but in the 1760s, physicians began becoming licensed for two reasons: first, to present dangerous or unqualified practitioners from injuring the public, known as fraud control; and second, to ensure greater education, training, and standards for practice, and I call this quality assurance.

Later, states made it a crime to practice medicine without a license. Under these licensing laws, naturopaths, massage therapists, acupuncturists, spiritual healers and others were prosecuted for practicing medicine without a license. In fact, "go to jail for chiropractic" was an early slogan for the profession. Since then, four major groups of providers in CAM have gained licensure in various states: chiropractic, massage therapy, acupuncture and traditional Oriental medicine, and naturopathy.

There are at least three historic models for licensure: mandatory, title and registration. These are three distinct models, although a lot of times legislatures confuse the terms. Mandatory licensure is exclusive. It means that practicing the profession without a license is prohibited.

Title licensure means that anyone can practice, but only persons with the designated title, for example, certified massage therapists, can use that title. Registration means that, to practice, a provider has to register their name, address and training with the state agency, which has the power to receive consumer complaints and revoke registration.

Now there are two additional avenues for regulating professional practice: the first is exemption. For example, often religious healers are exempt from medical licensing laws so long as they are practicing within the tenets of a recognized church and do not recommend medication.

The second is the Minnesota model, which you may have heard something about, which allows non-licensed providers to practice, as long as they meet a number of requirements. For example, they must not render a medical diagnosis or engage in fraudulent advertising or deceptive conduct. So these five approaches represent basic models for licensing and regulating.

Now the Tenth Amendment to the U.S. Constitution reserves to the states the police power, the authority to determine who will be granted a professional health care license and what the requirements are for that license. State control makes licensure enormously complex.

Each state has a different licensing scheme with different statutory language regulations and then judicial decisions interpreting all of these rules. State legislatures usually rely on national professional groups to establish education and training standards for practitioners and accreditation standards for educational programs and institutions, but members of CAM professions themselves dispute such things as how much training should be required to get a license in any field or the extent to which their training should incorporate conventional medical models or whether such training and standards can truly encourage individualized treatment.

So licensure presents attention between the desire to increase state legitimization and standardization of CAM practices and the desire to keep CAM practice flexible, nonstandardized and linked to intuitive aspects of care. The possibility of decreased individualization and decreased time per patient that licensure presents, presents a possible dark side to licensure that can temper calls for increased standardization and nationalization, and this can create conflicts about the desirability of licensure, even within CAM professions, and temper interest in more uniform practice guidelines.

Now, once states decide to license a given class of providers, they must address the scope of practice. The map of licensure in CAM is complicated by the fact that some modalities, such as homeopathy or acupuncture, may be included within a scope of practice of several different professions. In other words, quite frequently no single profession has a monopoly on any given modality.

A related complexity is that licensed providers in CAM who exceed their scope of practice can be prosecuted for unlicensed medical practice, and some boundary issues between professions include whether acupuncturists can recommend Western, as well as Chinese herbs, whether chiropractors can recommend nutritional advice, and to what extent massage therapists can offer emotional counseling and support. So the potential for criminal liability creates fear and uncertainty in CAM practice, as it may be difficult to spot boundary violations.

Now, licensure, as you know, is one of several key legal issues, and they are all related, and some of the related issues include informed consent, malpractice liability and professional discipline. Some of the cases suggest that licensed providers may find that merely integrating CAM into conventional care, in and of itself, could result in malpractice liability, as well as professional discipline.

The regulatory framework governing CAM emerged in the late 19th Century, and regulation in this century requires wisdom and vision. Abraham Maslow proposed that human beings evolve along the hierarchy of personal needs. He called them survival, safety, "belongingness," esteem and self-actualization.

Similarly, from my perspective, legal authority might evolve along a hierarchy of regulatory needs. These include fraud control, quality assurance, health care freedom, integration and human transformation. These needs are not exclusive, but they do potentially represent different stages of thought about regulating CAM.

For example, fraud control and quality assurance, which you have heard a lot about, are important aspects of licensure, but they are neither the only nor the controlling variables. I will briefly describe the other three as I see them.

The value of health care freedom respects the flow of information such that consumers can make intelligent, voluntary, and autonomous decisions. Integration reflects the value of learning ways in which different medical systems, across cultures and across time, can teach our health care system today.

Finally, transformation reflects the value of protecting the aspect of CAM that deals with personal, as well as social, wholeness. At its broadest and deepest level, transformation involves the maturation of humanity toward notions of individuation, fulfillment, happiness and even enlightenment and planetary evolution.

A unified approach to regulation would account for all five levels. For example, (1) How can states protect consumers against fraud; (2) How can states encourage standards; (3) What kind of licensure or regulation most clearly enables consumers to make their own informed choices about health; (4) Which approach best respects the integration of different healing models, cultures and traditions; and (5) What kind of licensure or other regulation will best facilitate human transformation.

Such a unified approach has the potential to transcend the sectarian factionalism, turf battles, and professional monopolies that have dominated licensure, and thereby focus on compassion, healing and the best interests of the patient.

So, to summarize, there are five overarching policy considerations that set the framework for licensure in CAM:

First, many providers want licensure to gain legitimacy and avoid criminal liability under medical license laws.

Second, licensure is largely a matter of state law. States rely on the professional organizations to set standards and structures.

Third, licensure has a potential dark side, in terms of diminishing the heart and soul of CAM practice.

Fourth, several licensed CAM professions may share legal authority to practice a given modality.

Five, there are at least five different models for licensing CAM providers.

A state may choose mandatory licensure, title licensure, registration, exemption, the Minnesota model or some variation or combination of the above. Such a choice may emphasize varying combinations of controlling fraud, quality assurance, health care freedom, integration or facilitating transformation.

I hope that these five overarching principles can serve as touchstones in future debates concerning CAM licensure. By articulating these principles, the White House Commission can help guide the states in their own deliberations.

Lastly, the power to articulate principles is the power to create. Let us create the world that we choose and not the world we have inherited.

Thank you.

DR. GORDON: Thank you, Michael.

DR. LOW DOG: I want to thank all of you for your presentations. I would like to actually talk to both Mr. Cohen and Mr. Landry.

I would certainly agree with you that, as far as comparison of pharmaceutical drugs and other things, that when you compare most natural remedies that are used appropriately, that there is far less risk of side effect or adverse reaction because they are far more dilute compounds, which is why, often, they take longer to work and they are usually less associated with so much toxic side effects.

I think we would all agree, though, that plants are pharmacologically active substances, and they can be used inappropriately, and that given the right circumstance, people can use them harmfully.

We had a patient recently, it was a couple of years ago at the VA Hospital, who was admitted in what looked like florid Digoxin cardio-toxicity, who had been given, from a local healer, a remedy for his failing kidneys, which had actually worked quite well for his failing kidneys, but he didn't have failing kidneys. He had congestive heart failure.

The plant that he had been given is very effective for congestive heart failure. It is inmortau [ph], which actually contains the cardenolide cardiac glycoside. However, he was toxic from it. It wasn't an interaction, it wasn't used with anything else. There are better ways to deal with congestive heart failure. Sometimes the problem with unlicensed therapists is that we don't know what we can't treat. We don't know where we step out of our boundaries or our scope of practice.

Now, do you feel, either one of you, when you are talking about licensure and scope of practice, other than an informed consent, should there be any scope of practice for herbalists, just an herbalist? Should there be any type of scope of practice there? Should there be any sort of licensure, education requirement, anything, so that we don't harm the public?

MR. COHEN: If I could just add a couple of correctives. First of all, thank you for quoting me, but it was not my conclusion that licensing boards are ineffective. I simply cited other scholars who have done original research, who have done that conclusion as a kind of warning that licensing boards don't always do what we hope and expect that they will.

Secondly, I am personally neither in favor of nor opposed to licensure. I simply tried to point out that there is a possible dark side that has to be taken into account as a kind of corrective.

Thirdly, the purpose of licensure is not simply to control fraud and create standards, but there are other potential values that come into the mix. Specifically, in terms of scope of practice there is a legal rule called the Duty to Refer, which basically says that when providers, such as chiropractors, exceed their scope of competence, they must refer to a medical doctor.

I would say that the Duty to Refer is a good generalizable principle for other professions, but at the point of the scope of competence, not the scope of practice, which is set by the standard, but the scope of what they are skilled and trained to do. At the point that that is exceeded, one should then refer the patient to somebody else, and that provides a kind of safety valve of protection.

It is a little bit complicated with herbs because, as I mentioned, one modality can be the province of several disciplines. So that is a big political battle, largely at the state level: who should have the authority to recommend herbs; what kind of evidence is required; should there be comparable training for M.D.s and non-M.D.s in this area. These are all open questions.

DR. LOW DOG: But you have made an assumption, though, about scope of practice and the ability to refer, the duty to refer. A chiropractor has training and is licensed.

I am not talking, really, about culturally intact healers. I am really talking about a lot of people who have read a few books and are healers. They are probably very well-intentioned and big-hearted, good people, but they may not have the training to actually know when they should refer. You have to have some basis to know when you are supposed to refer.

Giving an herb for your kidneys not working --

DR. GORDON: Tieraona, excuse me. Are you asking a question?

[Laughter.]

DR. LOW DOG: That was my question. Again, my question just comes back to, how would you know to refer?

DR. GORDON: So, Michael, do you want to be any more specific about any thoughts about licensure in this area?

MR. COHEN: Sure. Let me just clarify that if I could.

The duty to refer applies to licensed professionals. If somebody is unlicensed, and they are doing something that could fall into a licensed category, for example, diagnosing and treating disease, they could be prosecuted for the unlicensed practice of medicine, and possibly other professions as well.

So the unlicensed herbalist who recommends an herb and doesn't know what they are doing could be prosecuted for unlicensed medical practice. I hope that helps.

DR. GORDON: Okay. Thank you.

Wayne, George, and Tom.

DR. JONAS: Even if they do know what they are doing, they could be prosecuted.

It seems like we have an experiment going on, a natural experiment going on right now, at least with the Minnesota model, that might be worth evaluating. Although, I dare say it would be clear that you would see less adverse effects from natural treatments precisely because the insurance malpractice data that you described, which has, in my opinion, to do with the severity of the illness and of the treatments that are provided, not because one system is any worse or better than another.

Anesthesiologists have very, very high malpractice, and it is because of the risk of the type of practice that they are involved in. This, to me, is data that is not very useful. It is more polemic than anything.

My question really is, is there a role for the federal government in licensure, since it is under the state purview? What is our job here? Do we have any role on this, as a federally commissioned agency, to be involved in this at all? And if so, what would that be?

DR. GORDON: Michael, do you have any thoughts?

MR. COHEN: I wrestled long and hard with whether I could come up with any recommendations, and I think I made the choice not to, not to pass the buck or get off the hook, but simply because so much of it is dependent on state law, and so much of it occurs on a local level and is experimentation involving public bodies, a lot of debate, and a lot of it really is judge-made law, things like scope of practice, the duty to refer.

And so, in part, I think the debate is out of the hands of the Commission. But I think, that having been said, one can set overarching principles to try to shape the debate: What are the values that CAM represents; what are the values that this body has said is its overarching themes; are there other things to look at once we get beyond the debate about standards; and is licensure a good thing or a bad thing; and, what are the pros and cons.

So I think that by creating a very rich template for the debate, the Commission can then guide the states that are going to go on and repeat the debate in their own terms.

DR. GORDON: Sharon Hall, any thoughts?

MS. HALL: I agree pretty much with what Michael has said. From the medical malpractice perspective, we utilize standards of practice or scope of practice to identify or to defend a claim.

First of all, we do not insure anybody who is unlicensed or not certified, and I don't feel that my company would go into a state that did not have licensed or certified, say, naturopathic physicians or acupuncturists, and insure them.

So, from that perspective, we are focusing on a certain type of CAM practitioner that we feel very comfortable with that gives a certain standard of care. By their very nature, I think we have isolated some of those type of practitioners to provide the type of care that, from an insurance perspective, we would like to see given to the public.

DR. GORDON: Thank you.

George?

MR. LANDRY: I would like to respond to the question, Dr. Gordon.

DR. GORDON: Sure.

MR. LANDRY: I think one thing that should be abundantly clear, in the history of this country, we are constantly debating and battling over to what extent government gets involved in the lives of the people. Where something may have been appropriate 50 years ago, may not be appropriate today, and I think that is something we always have to pay attention to because some of the things that may have been appropriate 50 years ago may be exactly what has caused the problems today.

That is always something that has to resonate in the back of our minds as we grapple with the role of government in the lives of the people.

DR. GORDON: Thank you.

George, and Tom, and then Joe.

MR. DeVRIES: Question for Michael Cohen.

I know in the organization I work with -- I work with health plans to help them provide benefits for employers -- and I think, consistent with what Sharon Hall has said, the understanding of what we see is if the provider isn't licensed, then there is really no ability to work with them from a position of third-party reimbursement.

From the position of the Commission, as they look at what kind of influence they can have across the country as related to CAM, while the states regulate health care, potentially the White House Commission could recommend minimum statutes related to licensing of provider groups like acupuncture and naturopathy.

What would be your thoughts related to that? It ultimately would come down to the states' decisions, and they would have to enact licensure or statute, but would we be appropriate to make a recommendation?

MR. COHEN: I am trying to understand your question. Are you asking whether you should recommend that specific providers be licensed in all states?

MR. DeVRIES: There is a tremendous inconsistency, for example, with acupuncture, on how it is licensed across the country. Naturopathy is only licensed in roughly 11 or 12 states, and there are active efforts to have it licensed in other states. Yet, for many states, they don't have a guidepost on which way to go with these statutes, and they are looking to what has been done before, but there is not a strong guideline for them in terms of what they could emulate and enact in their states.

MR. COHEN: I think a couple of things could be done. One is the House of Lords recommended, basically, that the professions consolidate their regulatory bodies so that they make more sense.

You could recommend that if there is a non-licensed profession, for example, energy healing, that groups in that therapy, aroma therapy, that they come together and create more coherent professional structures because those professional structures can be prerequisites to licensing, as they have been in the other professions. So if that is a desirable goal, that is one recommendation.

On the other hand, I think we have already talked about some of the problems, in terms of having uniform standards, the second part of it. There would be more consistency. Inconsistency is a problem. For example, for physicians who want to refer across the states, they don't know what an acupuncturist means in Tennessee versus in Alaska.

On the other hand, the problems of greater consistency should also be acknowledged, the uniformity, the standardization. So that, some of the problems of medicine might be repeated in CAM, which I refer to as losing the heart and soul of practice, again, recognizing that tension.

So I would not necessarily be in favor of mandating consistency, but perhaps encouraging a study of what could be done to harmonize some of these issues.

Finally, I think it would be difficult to come up with a recommendation as to which providers should be licensed uniformly across the states. Acupuncture, there are 37 to 40 states that license non-M.D. acupuncturists, but when you look at the broad spectrum of CAM, which professions are you going to recommend that they obtain licensure, and on what basis, and what are the criteria that you would select that would give a profession candidacy for licensure?

In my own experience ... these issues are very, very thorny at the state level, and they are very complex and really require a lot of input. So it would be nice to have national policy on these issues, but I think that it is very complex and, in practice, may be a hard thing to achieve.

I hope I have started to answer your questions.

DR. GORDON: Thank you.

Tom?

MR. CHAPPELL: Michael Cohen, I would like to ask, since you have made clear that you don't have a recommendation for licensure or non-licensure, could you tell us how you would go about, as a consumer, discerning a CAM practitioner for you or a member of your family?

MR. COHEN: If I understand the question, it is whether licensure is important, or how important a variable is the fact that somebody is licensed and making a choice.

MR. CHAPPELL: That is another way of looking at it. I am really just asking, how would you make a selection, as a consumer, and is licensure important?

MR. COHEN: If I take off my "scholarly hat," I personally go to providers through a variety of routes, some of them are recommended by a physician, some are licensed, some are not. Some people have the highest certification and use science- and evidence-based medicine. Others use intuition.

When I go into a health food store, how do I pick echinacea versus some other supplement? Do I read what the JAMA says? Do I consult with a physician? Do I listen to my grandmother? Do I throw the bones and consult the spirits? Do I trust my own intuition? Do I talk to friends? I think that all of these things are important to me.

So, from a public policy perspective, the question is which sources of information, if I could just reframe it a little bit.

MR. CHAPPELL: Yes.

MR. COHEN: Are there sources of information, in addition to or beyond the mere fact that somebody is licensed, that one should allow into the mix, into the system, to influence consumers; is there a different way of thinking about it.

That is why, provocatively, I put in this goal of transformation, because, it seems to me, that transformation is the heart and soul and essence of a lot of therapies that we don't understand, that we don't know how to look at, that may require skills training or an experiential base to incorporate.

Thereby, if that is an important goal, it just opens up the way that we look at this a little bit.

MR. CHAPPELL: So discovery might be dampened by a licensing requirement. I think you have said that, actually, in your paper. That is helpful. Thank you.

MR. COHEN: I am just saying I think we should keep an open mind, and I think, as Wayne Jonas said, we are in a period of experimentation, where things that came in in the 1700s might look different in 50 years.

DR. GORDON: Thank you.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Regulation and Certification in the United States Michael Cohen, Esq., lecturer on medicine at Harvard Medical School, Boston, MA, spoke on regulation and certification in the U.S. from a legal perspective.

In contrast with the U.K., every state in the U.S. has its own licensing scheme, different laws, regulations, and courts and judicial documents that interpret these rules. "Who is authorized to practice which specialty" is determined by state. Further, the system is often "patchwork" from town to town and county to county. Mr. Cohen explained the four levels of the U.S. model: (1) mandatory licensure, the most common; (2) title licensure: needing a license to claim a particular title such as "massage therapist"; (3) registration, with the designated state agency; and (4) exemption from licensure requirements. A hypothetical example of number 4, exemption, would be a religious healer who is allowed to practice only under the tenets of a recognized church and only by using prayer, not prescribing medications.

He discussed boundary issues that arise between the professions; e.g., a healer who crosses the line of his own scope of practice can be prosecuted for unlicensed medical practice. The outcome of these situations depend on each state's own interpretation.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

The seminar will be a basic and wide-range exploration of healing practices originating around the world and often understood as complementary and alternative medicines (CAM) in the USA. We will be exploring several traditional systems of medicine as they contibute to the development of integrative medicine. We will attempt to examine the variety of medical practices in a critical and balanced way.

The study of the CAM will include four aspects: (1) the local knowledge and theories of healing and illness; (2) the philosophical, historical, and political dimensions; (3) a review of some plausible psychobiological mechanisms that may underlie many CAM practices; and (4) a review of the clinical efficacy of complementary and alternative medicines provided by the Western biomedical sciences.

At the end of the seminar students would gain a critical and balanced understanding of the benefits and limitations of complementary and alternative healing practices, which is very important considering the enormous popularity of alternative medicine today.

Students are required to do all assigned readings by class time, to complete weekly critiques and to participate in class discussions. There are two short (5-7 page) reflective essays and research paper (12-15 pages) required to complete the course. Students are also asked to participate in experiential activities within the class (e.g. Heart-Math), as well as experiencing some aspect of the healing method chosen for their research.

Heart-Math is the name of an institute that is exploring the role of the heart in human performance. They have devised a series of techniques that allow the practitioner to control heart rate variability and achieve "entrainment" or synchronization of mind, breath and heart rhythms. This entrainment state leads to lower stress and enhanced performance physiologically and mentally. While Heart Math is not an alternative medical practice as systemic knowledge from another culture, it nevertheless focuses on the interrelationship of the heart-mind that is fundamental to many cultural practices. Furthermore, the Institute is researching the relationship from a western scientific perspective and provides both a practice and an intellectual research design component that will help to elucidate a number of issues raised in the course.

There is a brief training to learn the Heart-Math technique. Students are asked to practice on a regular basis and to keep a record of their progress -- computer generated data as well as impressions and experiences.

A three page essay, reflecting on one's own experience with Heart-Math will be required at the end of the semester.

Guest healers, guest speakers, films, and healing demonstrations will supplement the lectures, readings, and class discussions. Students are strongly advised to attend the public events on CAM.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of The Institute for Integrative and Energy Medicine, a nonprofit organization exploring legal, regulatory, ethical, and health policy issues in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, naturopathic medicine, homeopathy, massage therapy, energy healing, and herbal medicine) and conventional clinical care. Michael H. Cohen is author of books on health care law, regulation, ethics and policy dealing with complementary, alternative and integrative medicine, including Healing at the Borderland of Medicine and Religion, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).