Complementary and Alternative Medicine Legal Issues

Context for CAM regulation, tying in some history of medicine with the history of regulation. Secondly, I’ll discuss key legal issues that are confronting providers and institutions. Thirdly, risk management strategies and finally some thoughts about the future, the evolution of CAM regulation.

So first I’d like to say that politics, perception and economic control of healthcare have created and continue to create the legal environment for CAM. Let me give you some examples. In the early part of our history, the first 150 years we had sectarian medicine, rivalries between competing sex and this directly led to medical licensing statutes, which happened to define the practice of medicine extremely broadly and made unauthorized practice criminal.

In the next 70 years, we had the rise of scientific medicine, the growth of the AMA and the Flexner Report and this led to U.S. versus Dent in 1888, in which the Supreme Court decided that states have very broad, virtually unlimited police power in health care licensing and other affairs.

The next part of our history, 40 years, we have technological triumphs, increasing scientific optimism and also the phenomenon of medical paternalism, the idea that the white coat doctors knows best, patients not having the authority to make decisions. And in the regulatory side, we have successful prosecution of individuals practicing naturopathy, chiropractic massage, hypnotism, even things such as ear piercing, tattooing and iridology and midwifery, all these providers are prosecuted under that broad definition of medicine.

The next 30 years we have a bit of a turnaround. We have the birth of bioethics and the recognition that technology perhaps does not have all the answers that we’re seeking. We see a failure of the war on cancer and a rise of public interest in CAM and in Wilk versus AMA, the court finds an AMA conspiracy to eliminate the chiropractic profession, so a bit of a change in the tides.

And most recently on the federal level in terms of legislation, we have congressional establishment of the National Center and we have the Dietary Supplements Health Education Act and just a word about this, the gut of it is that manufacturers need not prove safety and efficacy for dietary supplements.

However disease claims which link a supplement to a disease, do require significant scientific agreement. And finally, the proposed Access to Medical Treatment Act, which would broaden patient access to therapies outside FDA approval.

Now on the state level, we also have a number of medical freedom acts. These are statutes which provide that no physician shall be subject to discipline by state medical boards solely based on use of CAM. And these were enacted in response to a number of cases, which I won’t take the time to go through today. Also,

we have very widespread licensure of CAM providers. We have chiropractic in every state, acupuncture in 38 states, massage therapy, 32 and naturopathy, 11, so very widespread licensure.

Now, there are at least seven major areas of law that all interrelate to create the regulatory framework for complementary alternative medicine.

1. Credentialing and licensure,
2. Scope of practice,
3. Malpractice liability,
4. what I’ve called access to treatments,
5. Professional discipline,
6. Third-party reimbursement
7. Healthcare fraud.

And not only are these the major areas of law involved in CAM regulation, they’re also major components of what I call a legal audit of practices and policies.

So for example, somebody stopped me in the hall yesterday and asked “A massage therapist in my office is very good with acupuncture needles but also has no training. I don’t supervise her. Is this legal? Am I at risk?”

I think you probably know the answer but I want to give you just a framework for how you would analyze these kinds of questions using the different areas. So some questions I would ask under credentialing and licensure are, is the provider licensed in the state? If non-licensed, is the provider conceivably engaged in the unauthorized practice of medicine?

And finally for the physician, is the physician or other referring healthcare provider aiding and abetting the unauthorized practice of medicine by a non-licensed provider? These are questions that you should be asking.

Secondly, if licensed, is the provider practicing within the scope of practice authorized for their licensure?

1. does the statute expressly delineate the scope of practice? Does it say what you can and can’t do?
2. does the applicable regulatory board established regulations pursuant to such a statue, which further spell out the terms.
3. And finally, are there cases interpreting the statute?

Judges don’t make law, they only interpret the law, but many of these cases actually do make laws so they have to be considered. For example, is an acupuncturist authorized to dispense herbs within that jurisdiction or even something as basic as is a chiropractor authorized to render nutritional advice by that state? In some states when chiropractors have given nutritional advice, courts have said that they’ve crossed the line into prescribing drugs and therefore they have not practiced chiropractic but rather medicine.

And finally at one point does a massage therapist who provides emotional counseling during the session, crossed the line into unauthorized practice of psychology? See the point of the history part of the presentation is to say that nobody sat down in the legislature or the Congress to design an integrative system of CAM regulation.

These things developed out of certain context and in some sense, they leave us with a very piecemeal system that divides the patient into parts and assigns each part to a different provider rather than saying, this is a whole system and how are we going to look at change? Now third malpractice and I’ll go into this in some depth in just a few minutes, has the provider deviated from the standard of care applicable to the profession in question?

This is the number one element of malpractice and the second element, has this deviation in fact caused the patient injury? Now one way to analyze this is to say, will the court view the very use or integration of a CAM therapy as the requisite deviation from the standard of care? And we don’t know because there’ve been very few cases so far.

And the second question is, will the court trace the cause of the patient’s decline to the CAM therapy? Will they say that it was that therapy that caused the injury rather than the progression of the disease?

The fourth area is access to treatments and briefly just to say, is the treatment considered a new drug which requires FDA approval under the federal Food, Drug and Cosmetic Act? And secondly, has the provider made any warranties, representations, guarantees or claims? These are all things to stay away from. Regarding a therapy or otherwise used dietary supplements in a way which conceivably could trigger some FDA enforcement action for distribution of an unapproved, new drug in interstate commerce. Now this is a remote possibility, but I just mention it because the FDA tends to read it’s jurisdiction very broadly and I want to make you aware of this.

And five, professional discipline, has the provider delivered a CAM therapy which could be said to depart from prevailing and acceptable standards within the profession? This is the statutory language that often accompanies the physician licensing statute.

Physicians can be disciplined for gross misconduct for practicing under the influence of alcohol or drugs. And then there’s this general language departing from prevailing and acceptable standards. And does the state in which the provider practices have a statute precluding disciplines solely based on use of CAM and even if so, are there any cases interpreting the law and will the statute in fact provide legal protection? Six, third-party reimbursement, is reimbursement mandated by any willing provider or other legislation? Do experimental treatment exclusions in the policy precludes covers?

For example, might acupuncture be deemed an experimental treatment? Even if it’s not experimental, is the treatment deemed medically necessary if there’s a limitation in the policy to therapies that are deemed medically necessary?

And finally, could submitting the therapy for reimbursement trigger investigation under state law for insurance fraud? Seven’s healthcare fraud, could the treatment be construed by somebody in the government whose job it is to look for these kinds of things, could it be construed as worthless and fraudulent, thereby triggering federal prosecution under fraud and abuse laws? If the therapy is determined to be medically unnecessary and the provider is said to have known or had reason to know, but nonetheless submitted the bill, could the provider be prosecuted for fraud and abuse? How will agencies engaged in coordinated enforcement efforts interpret the ambiguous and undefined new federal crime of healthcare fraud?

Now when I was asked to comment on the Kennedy-Kassebaum bill, my suggestion was that there be at least some language in some of the committee reports that the practice of alternative medicine shall not in and of itself be equated with healthcare fraud because this term was undefined and so that language now is in the report, so that’s very helpful. I hope it’s helpful.

Okay, let me give you two cases.

Case one is the case of physician delivery of CAM in cancer care.

Case two, the case of physician referral to a CAM provider.

So case one, Doctor A used hair analysis and nutritional care to diagnose and treat a cancer patient. The cancer cells metastasized and among other things the patient developed blindness and back problems. What legal result? This is sort of like a law school hypothetical. Well the patient sued presenting two claims.

Number one, negligence, arguing that the physician had persuaded her to forgo conventional care and to rely solely on the nutritional protocol. And secondly, failure to obtain adequate informed consent regarding treatment benefits and risks. This is actually a case that appeared in New York in 1997. It’s a trial court, so it’s not the highest court in the land and also what a New York court decides is not necessarily binding on other states.

However, it’s one of the few cases that are out there and courts like to borrow language, holdings, and principles from other cases and so it has to be reckoned with because it’s a reported judicial decision. The jury found that the treatment had indeed departed from good and acceptable medical practice and further that the physician who had a financial interest in the supplements he was prescribing, was motivated by greed and reckless in his care.

Now reckless is a step higher in culpability than negligence. And so the jury found also that even though the plaintiff had agree to the treatment and thus impliedly assume the risk of injury, pre-verdict damages were 4.5 million for pain and suffering and 200,000 for loss of earnings. Also because of the charge of recklessness, the jury awarded $150,000 in punitive damages. The punitive damages award was later set aside on appeal, but the rest remained. The court in some ominous language stated, “No practitioner of alternative medicine could prevail as the term nonconventional, may well necessitate a finding that the doctor who practices such medicine deviates from acceptable medical standards.”

And so the courts apparent conclusion is that integrative medicine is malpractice per se. Now I present this to give you some flavor for the way that judges think about these things or have thought about these things in the way that these terms which we talked so much about can have a very powerful effect because lawyers are wordsmiths and these can dictate conclusions.

Let me give you the second case, the case of referral. So in this case, Doctor B treats a cancer patient with chemotherapy and also refers the patient to A, a licensed acupuncturist. Payment for the acupuncture visit is made by the same HMO that covered Doctor B. Well Doctor B speaks with the acupuncturist once prior to the treatment and learns that A uses needling together with standard herbal formulas to relieve nausea and other side effects of chemotherapy. Now for purposes of this analysis, assume that A is negligent.

For example, assume that this particular acupuncturist fails to follow clean needle technique, which would mean that that person has departed from the standard of care in the acupuncture profession and thus is negligent. Or suppose that the acupuncturist uses an herb that’s not indicated for this patient or condition or that’s agreed upon in the profession. Or suppose that the acupuncturist uses herbal medicine where it is outside their legally authorized scope of practice. The patient then suffers an adverse reaction or dies and plaintiff or plaintiffs’ heirs sue the physician for the malpractice of the acupuncturist. Is there liability?

Now the physician’s argument is going to be the general rule that a referring physician is not liable for treating provider’s negligence. That’s the general rule and if we left it at that, we could just end it there. However, there are a number of exceptions and the exceptions may in fact swallow the rule and let me present these as the patient’s arguments to the court.

The first argument will be that the physician is directly liable because the referral itself is negligent. In other words, the argument would be that the referral to the acupuncturist delayed or deferred necessary medical treatment.

Another argument or a subset of this is that the acupuncturist was not a competent practitioner and that the physician knew or should have known and thus was negligent because he should have known or she should have known that the acupuncturist would not follow the clean needle technique, would use a dangerous herb or might prescribe herbs outside their scope of practice?

So obviously, before I get into risk management, what this implies is that some minimal amount of due diligence is good legal protection. And also I’d like to say that sound clinical judgment and legal protection ideally coincide. So it’s good to know to whom you’re referring and what they’re doing.

I don’t believe in an ostrich in the sand approach. Many people use this logic, I’m afraid of liability so I won’t keep track of what’s going on. Therefore we’re independent and separate and liability won’t flow to me. I think that this scenario militates in favor of more knowledge, more information, more sharing.

And for the second argument, the plaintiff would argue that even if the physician is not directly liable, in other words has not been negligent, Doctor B is vicariously liable for A’s negligence because A is considered an agent of the physician. So vicarious liability again means one is not directly liable, but rather somebody else’s liability simply flows up the chain and here are some ways to flesh out that argument. Number one, there could be a state statute which requires physician supervision of acupuncturists or at the very least written referral and consultation for patients with serious diseases. And this statute by its term, makes the acupuncturist an agent and thus creates vicarious liability.

The acupuncturist is also an agent because arguably the two providers are horizontally integrated in the same HMO plan and thus are providing what’s known as joint care, so they’re agents for one another or the argument might be made that the physician and the acupuncturist spoke at least once regarding A’s treatment plan and thus the two were engaged in a joint treatment or concerted action, which by law also creates an agency relationship.

Now how can one practice integrative healthcare without engaging in joint treatment or concerted action?

So the conclusion would be that the physician is directly liable and or vicariously liable for the A’s … for the acupuncturist’s negligence. Again, the agency exception and direct liability can swallow the general rule that there’s no negligence for referral.

So note, the less that the physician is involved with the acupuncturist, the more separation, the greater the risk of direct liability for negligent failure to supervise or direct liability for a negligent referral. On the other hand, the more the physician is involved, the greater the risk of agency and therefore a vicarious liability for the acupuncturist’s care. Therefore, the physician is caught between the Scylla of insufficient integration or direct liability and the Charybdis of excessive integration or vicarious liability.

Further, the situation has a domino effect potentially, civil malpractice liability. The patient sues, state medical board investigation. The board commences disciplinary proceedings and evaluates whether to sanction the physician and or revoke his license. Criminal liability, the physician could be prosecuted for aiding and abetting the unlicensed practice of medicine if the acupuncturist exceeded the scope of practice as well as negligent homicide if the patient died as a result.

And finally coordinated federal and state enforcement activities, other agencies intervene with the stated aim of targeting healthcare fraud. Now part of my job is to present the worst-case scenario, so this is what I’m presenting. That’s the extent of the humor in this talk.

Okay, so risk management, what strategies should a physician adopt to help protect against unwarranted malpractice liability exposure? And can such strategies be generalized as different groups of providers and institutions think about ethically appropriate, clinically responsible and legally defensible ways of integrating CAM. And this is something that David and I have been talking about and I really believe that the legal and the clinical must come together here. So let me give you a preliminary framework for that.

Number one, it’s very important to determine the clinical risk level and as a subset of that I’ve put, understand all relevant and applicable herb-drug interactions or potential contraindications to the referred to therapy. Beware of therapies such as hair analysis that undermine confidence in clinical rigor and document and justify utilization of CAM therapies with peer-reviewed literature. All of this together will help bring the therapy closer to conventional standards of care, thus meeting the first element of malpractice, not deviating too far from the conventional standard of care.

Secondly, very important to continue to monitor the patient conventionally. Do not abdicate conventional diagnostic and therapeutic techniques. Do not even give a hint of dissuading the patient from necessary conventional care. Now I’m giving you the most conservative advice based on the lessons from Charell versus Gonzalez.

And third, consider assumption of risk in some states and the law really does vary quite a bit from state to state.

The physician has a complete defense if the patient executes a written statement in which the patient expressly assumes disclosed risks of a CAM therapy and this principal comes out of Schneider versus Revici, 1987, the Second Circuit Court of Appeals. This was the holding and it’s very compelling and very powerful. Now, we could go more into this in the Q and A.

I was very moved last year and also this year by David Rally’s presentation on the therapeutic relationship and there’s some extent to which putting a form … thrusting a foreman in the patient’s arms in a very formulaic and bureaucratic manner does not necessarily advance the goals of the therapeutic relationship. So the way that this is done, the kind of form, the way that the conversation is molded, all these things require a lot more consideration. And also a form is not the true defense, physicians still must use reasonable care in selection and execution of CAM therapy. So again, it’s important to be clinically responsible and not simply rely on assumption of risk as a defense.

But let me offer some strategies for referral for CAM therapies and I’ve said apply “credentialing strategies” in quotes because, this isn’t really credentialing in a sense that the individual doctor is not credentialing other providers in the way that an institution is, however, some of the strategies overlap.

For example, if the practitioner’s licensed, it’s a good idea to know that and have evidence of their license or registration number. Number two, understand the required education and clinical training of such a practitioner. And number third, understand whether the practitioner’s licensure requires physician supervision, for example, acupuncture and traditional oriental medicine in some states. Make sure the provider’s offering services within his or her legally authorized scope of practice. For example, in some states, acupuncturists do not have authority to practice herbal medicine. This is a good thing for a referring physician to know.

Fourth, check the provider’s history of malpractice litigation and make sure it is tolerable. Determine whether the provider has been subject to professional discipline and whether the provider has minimum malpractice insurance, for example, one million, three million and that way the person who’s referring does not become a deep pocket. There’s another insurance company in between.

Finally, for the last part of the presentation, apart from risk management strategies in specific situations, how do we collectively as a community, create a legal environment that is more favorable to safe, effective and appropriate integration of CAM with conventional clinical care? Well as a starting point, I believe we should address at least four crucial areas.

Number one, liability, number two, professional discipline, number three, ethics and number three bioethics.

First: liability, one strategy might be to create model guidelines to help providers and healthcare institutions both nationally and internationally to navigate these complex issues. Providers should not be left on their own to go out and hire attorneys and figure out what to do on an ad hoc basis. I believe institutions should take responsibility and work with policymakers and government agencies to formulate guidelines that can help people in everyday practice, navigate through these difficult issues. And also, such guidelines can provide leadership and help dissipate any notion on the part of judges that for example, integrative medicine constitutes malpractice per se. So there is a remedy, if you will, for the situation and this is one way to go at it.

In terms of professional discipline, I believe we need to create model guidelines for state medical boards that create a balance between various regulatory goals such as consumer protection on one hand and consumer freedom on the other. And if you look at the Texas Medical Board, state medical board rules on complementary and integrative medicine, they explicitly try to do this. They recognize that there is a role for consumer choice as well as for the state taking the authority to protect consumers from their own ill-advised choices. So it’s about having a balance and such guidelines also can help dispel the notion that integrative practices per se are fraudulent deviant or dangerous.

In ethics, we can create model guidelines for delivery and referrals which explain traditional concepts such as non-maleficence and beneficence in the context of CAM. And it’s of course axiomatic that one should not provide a CAM therapy that does harm, that’s unsafe, but perhaps there’s some way to interpret principles such as do no harm. And I’ve contrasted it with this term ahimsa, just to show that there’s some bridging there and that we can include perspectives derived from CAM therapies. And I’m leaving that deliberately ambiguous because I think probably there are people in the audience that are going to write books about this. In bioethics, to create model guidelines for end-of-life-care, reproductive technologies and other issues that are sensitive to the insights and discoveries beyond the biomedical model.

And I offer this because when I was teaching health law and bioethics, I was struck by how all of the cases and all of the models in the books from which I was teaching really come from the medicine that we’ve known … well BE, before Eisenberg or however one wants to demarcate the area of primordial chaos. And I think that the insights in this conference can help bridge medicine, ethics, law and spirituality. This is vitally needed. The future of regulation, where are we going?

And let me offer a very broad question, what is the ultimate purpose of all this regulation? I’d like to be just slightly provocative by invoking Abraham Maslow who spoke about the hierarchy of individual needs. And Maslow said that we have these five needs arranged in a pyramid, physiological, safety, belongingness and love, esteem and self-actualization. And his thesis was that higher needs, for example self-actualization, emerge only once lower ones, for example hunger, are gratified.

So it’s hard to be deeply spiritual and compassionate when you haven’t had a meal in five days. So all of these needs the higher and lower’s a bit pejorative, but the idea is that we can only reach ones, certain ones, once the other ones are met. And I think as we look at regulation, we can also see if you will, a hierarchy of regulatory needs, fraud control, quality assurance, healthcare freedom, functional integration and transformation and I’m going to define these.

And I’d like to acknowledge that each and every level of regulation is important, but higher needs such as integration and transformation can really emerge only once lower ones, for example fraud control, in the minds of regulators in the community are satisfied. And I believe that early on in our history we had a primary emphasis on fraud control. If you read the cases, you’ll see again and again, we’ve got to prevent fraud, we’ve got to prevent fraud.

Preventing dangerous practices and this corresponds to Maslow’s idea of meeting our physiological needs and modernly, are concerned with adverse or drug interactions, while not phrased in the same language, perhaps also corresponds to that very basic level of survival.

And the next level up would be quality assurance. We also like to promote professional standards so that products and therapies are safe. So we’re meeting our safety needs and modernly, we have an emphasis not only on patient safety, but also on cultural safety with therapies, a la Kaptchuk and Remen.

In the late 20th century, we’ve built on the first two regulatory goals and we’ve added very powerful notion of healthcare freedom. This goes back to the ethical maxim of autonomy, which is just as important as do no harm and some people assert it’s even more primary. And I define this goal as safeguarding the flow of information so that consumers can feel they belong to a system in which they can make intelligent and autonomous healthcare choices and this corresponds to a feeling of belongingness to community and love.

Fourth would be functional integration, advancing the safe, effective and appropriate integration and note the use of those terms. I’m not advocating one form of integration over another. I’m saying we need to look to integration that is safe, effective and appropriate of all world systems of healing, restoring patients’ participation in healing and care for the self and I believe this corresponds to the value of esteem. And finally, 21st century and beyond transformation, which corresponds to self-actualization, more than curing, transformation involves promoting healing of mind, body, spirit, igniting individuation, advancing human wholeness and moving toward individual and collective enlightenment on the scale of planetary evolution.

And I bring this in because I wanted to broaden out the narrowest liability concern, kind of create a larger context for this. So in conclusion, we must honor the balance between consumer protection and consumer freedom, between concern for patient choices and respect for those choices, between honoring … between viewing the body as a thing to be regulated and honoring the cultivation of being through the wisdom of the body and between the judgment of the state and the personal pursuit of that essential liberty and indivisible feature of our existence, known to us as human health. Thank you.