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Physicians and “CAM”

In the last 20 or so years, the popularity of so-called “complementary and alternative medicine” began to lure physicians (M.D.s and D.O.s) into employing CAM treatments, or what is now rebranded as “integrative medicine.” Of course, CAM use by a physician necessarily requires some deviation from the “conventional” standard of care. Because deviation from the standard of care can be grounds for discipline by the state medical board, state legislatures and medical boards in the United States have had to grapple with just how much medical practice acts and regulations should accommodate CAM use by physicians.

As it turns out, less than you might think.

Disclaimer!

Allow me to jump in early on with some qualifiers. This is not a law review article and I did not exhaustively research all 50 states statutes and regulations. Nor am I saying that if you are a physician and have practiced or recommended CAM you violated your state’s medical practice act or regulations. And, of course, no one practicing medicine (actually, no one period) should rely on a blog post for legal advice.  If you want to know the appropriate parameters for practicing CAM, or integrative medicine, or whatever you might wish to call diagnostic methods and treatments that have no plausible basis in science, call your lawyer and your state medical board.

Limitations on CAM use

That said, I did find several states with specific laws or regulations governing CAM practice by licensed physicians. I was pleasantly surprised to learn there are, in my opinion, some significant restrictions on use of CAM. Usually these laws say something to the effect that a physician cannot be disciplined by the medical board for use of “alternative,” “complementary,” “integrative” or “nonconventional” (the terminology varies) diagnostic methods and/or treatments if certain conditions are met. The most common limitation on CAM use, one which might not immediately strike the eye of the casual reader, is found in this New York statute (NY C.L.S. Educ. Sec. 6527), which provides this exception to conduct prohibited by the medical practice act:

The physician’s use of whatever medical care, conventional or non-conventional, which effectively treats human disease, pain, injury, deformity or physical condition.

Did you notice that the statute requires non-conventional treatment to be effective?

In fact, other states have similar restrictions on CAM use by physicians:

North Carolina (N.C. Gen. Stat. Sec. 90-14):

Medical Board cannot discipline a licensee solely because he used a therapy that is “experimental, nontraditional, or that departs from acceptable and prevailing medical practices unless, by competent evidence Board can establish that the treatment has a safety risk greater than the prevailing treatment or that the treatment is generally not effective.”

Oregon (O.R.S. Sec. 677.190):

Use of an “alternative medical treatment” does not constitute unprofessional conduct if “the physician . . . based on the physician’s professional experience has an objective basis to believe [it] has a reasonable probability for effectiveness in its intended use . . . and poses no greater risk . . . than the generally recognized or standard treatment.”

California (Cal. Bus. & Prof. Code Sec. 2234.1):

Physician not subject to discipline if use of “alternative or complementary medicine” provides “a reasonable potential for therapeutic gain in a patient’s medical condition that is not outweighed by the risk . . .”

Colorado (C.R.S. Sec. 12-36-117):

Physician not subject to discipline if use of “alternative medicine” provides “a reasonable potential for therapeutic gain in a patient’s medical condition that is not outweighed by the risk . . . “

Ohio (O.R.C. Ann. Sec. 4731.227)

Physicians may use alternative treatments if it is “reasonable when the benefits and risks of the alternative medical treatment and the conventional medical care are compared.”

In other states, similar provisions are contained in the medical board’s regulations:

Louisiana (28 L.R. 1589):

Integrative or complementary medicine can be used “provided there exists a reasonable probability for diagnostic or therapeutic effectiveness in its intended use.”

Texas (22 T.A.C. Sec. 200.3):

The Texas regulation is somewhat confusing. On the one had it says that a physician cannot be disciplined for use of complementary or alternative medicine, “unless it can be demonstrated that such method has a safety risk for the patient that is unreasonably greater than the conventional treatment . . .” Yet, in another section, it states that a treatment must “be based upon a reasonable expectation that it will result in a favorable patient outcome, including preventive practices” and the treatment must offer a greater benefit than can be expected with no treatment.

If we look at the true CAM treatments typically employed or recommended by physicians, such as acupuncture, reiki, and therapeutic touch, I am not aware of a single one that is “effective” or provides “a reasonable potential for therapeutic gain” or is more beneficial than a conventional medical treatment. (I say “true” to distinguish therapies incorrectly rebranded as CAM, such as exercise and nutrition.) One wonders, then, how physicians using CAM in these states can avoid potential trouble with the state medical board.

Unreasonable risk

Other states have a lower standard for CAM use.

Indiana (Burns Ind. Code Ann. Sec. 25-22.5-1-2.1)

“[N]o reasonable basis to conclude that [the treatment] poses an unreasonable and significant risk of danger . . . “

Georgia (O.C.G.A. Sec. 43-34-38):

Uses the same standard as Indiana, but only for “any illness or disease which is potentially life threatening or chronically disabling.”

Alaska (Alaska Stat. Sec. 08.64.326):

Board cannot “base finding of professional incompetence solely on the basis that a licensee’s practice is unconventional or experimental in the absence of demonstrable physical harm to the patient.” This is true even though other reasons for determining professional incompetence (e.g.,violation of Board’s code of ethics or false advertising) do not require “demonstrable physical harm.”

However, the requirement that an alternative treatment pose an “unreasonable risk” before the imposition of discipline may not be the safe harbor it at first appears. In one case, a Washington physician used a galvanic skin response device to detect and treat allergies. The medical board disciplined him even though state law provided that “the use of nontraditional treatment by itself” is not unprofessional conduct as long as it does not “create an unreasonable risk that a patient might be harmed.” The Washington Supreme Court held that leading patients to believe that the device could diagnose and treat allergies, when in fact it could not, placed patients at a risk of harm. Thus, the court essentially grafted an effectiveness requirement onto the statute by finding that lack of effectiveness itself creates risk.

Patient protection

As noted, Louisiana and Texas require a reasonable probability of effectiveness. Even if a treatment could squeak by that one, these states have a fairly elaborate regulatory scheme for a physician’s use of CAM.

In Louisiana, the physician must have a treatment plan “by which progress or success can be evaluated.” (One wonders how the “success” of, say, reiki could be “evaluated.”) The patient must be seen by the physician at intervals to assess the “efficacy” of the treatment. Lack of progress or worsening of symptoms “shall indicate the need to revise the treatment plan.” In addition the patient must have an actual medical diagnosis, which would presumably exclude something like imbalanced qi. The physician must tell the patient a treatment is unconventional or unproven and its benefits and risks.

Texas’s regulations are even more stringent. In addition to requirements similar to Louisiana’s, the Texas physician must give the patient

a description of the underlying therapeutic basis or mechanism of action of the proposed treatment purporting to have a reasonable potential for therapeutic gain that is written in a manner understandable to the patient.

I’d like to see the “underlying therapeutic basis or mechanism of action” for homeopathy or acupuncture written out in an “understandable” way.

And:

All physicians must be able to demonstrate the medical, scientific or other theoretical principles connected with any healthcare method offered and provided to patients.

We have to presume that demonstration of CAM methods would necessarily fall under the “other theoretical principles” category.

As unfortunate as it is that Texas, and other states, allow physicians to use CAM, don’t we all wish that these same regulations would cover all CAM providers? Even if the regulation of nonsense results in nonsense, it would be nice to impose some actual patient protection on the process. (This as opposed to faux patient protection, like education and training in CAM.)

Federation of State Medical Boards

Louisiana and Texas apparently based their CAM regulations on the Federal of State Medical Boards (FSMB) 2002 “Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice,” which are to be used by state medical boards in formulating policy. (Other state medical boards may have done the same.) The Model Guidelines are interesting in that they reflect the sort of uninformed enthusiasm for CAM’s potential that I think has been tamped down somewhat by 10 years of unproductive research into CAM treatments. The Introduction speaks of “legitimate medical uses of CAM” and the Guidelines being “consistent with . . . [the] accepted standard of care.” The Guidelines themselves speak of the appropriateness of using CAM as based in part on the question of whether it has “adequate scientific evidence of efficacy.” Based on what we know 10 years later, no CAM treatment to date can meet these standards.

In April of this year the FSMB House of Delegates adopted a new “Essentials of a State Medical and Osteopathic Practice Act.” These documents (this is the 13th) are designed to “serve as a guide to those states that may adopt new medical practice acts or may amend existing laws.” Notably, while the Model Guidelines on CAM are still recommended (or, at least, they haven’t been taken down from the FSMB’s website), the model practice act does not contain any specific reference to CAM, nor does it contain any exception for CAM use to the list of conduct requiring “disciplinary or remedial action.” The Essentials do provide, however, the following grounds for discipline:

making a false or misleading statement regarding his or her skill or the efficacy or value of the medicine, treatment or remedy prescribed by him or her or at his or her direction in the treatment of any disease or other condition of the body or mind.

It would seem, then, that in any state adopting the model practice act, a physician would have to tell the truth about the efficacy of any CAM treatment he offered or recommended and not do it in a way that misleads the patient into thinking that the treatment is efficacious when in fact it is not. Again, I am not sure what CAM treatment could meet this standard based on the current evidence.

Two odd states

This brings me to my home state, Florida, which takes a unique approach. Although I can’t imagine that the legislature meant what it said when it passed this statute governing “Complementary or alternative health care treatments,”(Fla. Stat. Sec. 456.41) this is what the law actually says:

It is the intent of the legislature that health care practitioners be able to offer complementary and alternative health care treatments with the same requirements, provisions, and liabilities as those associated with the prevailing or conventional treatment methods.

Which sounds to me like under Florida law the CAM treatments must at least have some plausible basis in science and a reasonable expectation that they will actually work.

This is confirmed by the definition of CAM treatments:

any treatment that is designed to provide patients with an effective option to the prevailing or conventional treatment methods associated with the services provided by a health care practitioner.

But that’s not the reason I think the legislature didn’t realize what it was doing. (It happens.) It is perfectly reasonable for a state to require that CAM treatments be effective if they are to be used. Here’s the odd thing, though. Florida’s statute applies to all licensed health care professionals. So, in addition to M.D.s, D.O.s, dentists, nurses, and other science-based professionals, it also covers chiropractors and acupuncturists. Frankly, I don’t see how a subluxation-based chiropractor or an acupuncturist could practice at all.

Maybe they could wiggle out from under these provisions with the phrase “prevailing . . . methods associated with the services provided by a health care practitioner” by claiming it means that if a method is “prevailing” in chiropractic or acupuncture, they can use it. Thus, they could argue that detection of subluxations or rebalancing qi with needle sticks is exempted. On the other hand, the only time this argument would likely come up is when a patient claims the practitioner violated the statute by offering an ineffective CAM treatment. Normally, the defense would be that the treatment is, in fact, effective. But in this case the CAM practitioner would be put in the decidedly uncomfortable position of arguing that because the statute exempts “prevailing” treatments in his field effectiveness is not required.

And speaking of odd, we’ll close with a Massachusetts statute (A.L.M. G.L. ch. 112, Sec. 7) I discovered, which doesn’t really deal with physician CAM use but is too good to pass up. Massachusetts exempts the following from the commonwealth’s medical practice act:

clairvoyants or persons practicing hypnotism, magnetic healing, mind cure, massage, Christian Science or cosmopathic method of healing.

Cosmopathic healing? When I googled “cosmopathic” I was asked “Do you mean ‘sociopathic?'” but I did find this video on YouTube.

When cosmopathic healing becomes a licensed health care profession in the U.S., remember, you heard about it here first.

 

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