Should Integrative Medicine Legal Standards Drive Physicians’ Risk Management Practices?

Strong Risk Management
Physicians who incorporate complementary and alternative medical (CAM) modalities into their practice, or brand themselves as using integrative medicine, functional medicine, or similar approaches, often consult with our integrative medicine lawyers as to the best way to manage liability and regulatory risks.

One of the strongest and most common risk management tools is the physician-patient agreement.  Sometimes, particularly if the physician wishes to operate in a health coaching only role, we might call this a:

  • Wellness Agreement
  • Coaching Agreement
  • Subscription Agreement
  • Membership Agreement
  • Concierge Services Agreement

And the agreement will be with Clients or Customers, not Patients.

(For information about the physician’s health coaching model, see our E-Learning Platform and in particular, our course on Telemedicine Legal Roadblocks: Keys to a Successful Legal Practice).

The Agreement can contain elements of an informed consent form, with other legal add-ons and protective language, such as (for example) appropriate assumption of risk language.

Do Integrative Medicine Legal Standards Apply

In earlier years of integrative medicine, an important question was whether integrative medicine legal standards would apply, as opposed to the standards of conventional medicine.  This was important, because integrative medicine legal standards really didn’t exist.

What we had were mostly conventional physicians, often hostile to integrative healthcare, judging medical doctors in medical board disciplinary cases, according to conventional standards of care.

Now this may work well if the CAM therapy is an outlier, or completely inappropriate given the patient’s condition, but what if the therapy is supported by evidence, safe, and adopted by a respectable contingent of medical doctors?

Many would argue that this is the posture of functional medicine, for example.

In fact, some legal scholars that the conventional medicine standard of care should not apply to integrative medicine, and that instead, a “mixed standard” should apply (i.e., a mixture of conventional and complementary & alternative medicine).

The Federation of State Medical Boards—with a Twist

In a twist on this debate, the Federation of State Medical Boards issued policy guidance for state medical boards, with guidance on how to regulate physician use of complementary and alternative medicine.

Many state medical boards have adopted the policy guidance and model rule in whole or in part.  For example, the Texas Medical Board has enacted Standards for Physicians Practicing Complementary and Alternative Medicine in Title 22, Part 9, Chapter 200, Rule 200.3 of the Texas Administrative Code.

The rule states that its purpose is “to recognize that physicians should be allowed a reasonable and responsible degree of latitude in the kinds of therapies they offer their patients. The Board also recognizes that patients have a right to seek complementary and alternative therapies.”  This is a very liberal statement and consistent with the Federation’s message.

The rule then offers these definitions:

(1) Complementary and Alternative Medicine--Those health care methods of diagnosis, treatment, or interventions that are not acknowledged to be conventional but that may be offered by some licensed physicians in addition to, or as an alternative to, conventional medicine, and that provide a reasonable potential for therapeutic gain in a patient's medical condition and that are not reasonably outweighed by the risk of such methods.

(2) Conventional Medicine--Those health care methods of diagnosis, treatment, or interventions that are offered by most licensed physicians as generally accepted methods of routine practice, based upon medical training, experience and review of the peer reviewed scientific literature.

(3) Reasonable Potential for Therapeutic Gain--An expected beneficial outcome resulting from the application of a health care method containing medicinal or healing properties that is supported by scientific evidence and does not solely rely on placebo effect.

A key part of the rule is the definition of when physicians will be subject to discipline if they use a model of integrative medicine.  Again, the more liberal view (stated in the rule) is that:

A licensed physician shall not be found guilty of unprofessional conduct or be found to have committed professional failure to practice medicine in an acceptable manner solely on the basis of employing a health care method 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 for the patient's medical condition.

So far, so good, as it appears to be put the burden of proof of safety risk on the Board, and the standard is that the safety risk is “unreasonably greater” than the conventional treatment.

The next part, though, has a lot of requirements.

The Texas Medical Board will use the following guidelines to determine whether a physician's conduct violates the Medical Practice Act, §§164.051 - .053 in regard to providing complementary and alternative medical treatment.

(1) Patient Assessment. Prior to offering advice about complementary and alternative health care therapies, the physician shall undertake an assessment of the patient. This assessment should include but not be limited to, conventional methods of diagnosis and may include non-conventional methods of diagnosis. Such assessment shall be documented in the patient's medical record and be based on performance and review of the following listed in subparagraphs (A) - (D) of this paragraph:

(A) an appropriate medical history and physician examination of the patient;

(B) the conventional medical treatment options to be discussed with the patient and referral input, if necessary;

(C) any prior conventional medical treatments attempted and the outcomes obtained or whether conventional options have been refused by the patient;

(D) whether the complementary health care therapy could interfere with any other recommended or ongoing treatment.

(2) Disclosure. Prior to rendering any complementary or alternative treatment, the physician shall provide information to the patient that includes the following with the disclosure documented in the patient's records:

(A) the objectives, expected outcomes, or goals of the proposed treatment, such as functional improvement, pain relief, or expected psychosocial benefit;

(B) the risks and benefits of the proposed treatment;

(C) the extent the proposed treatment could interfere with any ongoing or recommended medical care;

(D) 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; and

(E) if applicable, whether a drug, supplement, or remedy employed in the treatment is:

(i) approved for human use by the U.S. Food and Drug Administration (FDA);

(ii) exempt from FDA preapproval under the Dietary Supplement and Health Education Act (DSHEA); or

(iii) a pharmaceutical compound not commercially available and, therefore, is also an investigation article subject to clinical investigation standards as discussed in paragraph (7) of this section.

(3) Treatment Plan.

(A) The physician may offer the patient complementary or alternative treatment pursuant to a documented treatment plan tailored for the individual needs of the patient by which treatment progress or success can be evaluated with stated objectives such as pain relief and/or improved physical and/or psychosocial function. Such a documented treatment plan shall consider pertinent medical history, previous medical records and physical examination, as well as the need for further testing, consultations, referrals, or the use of other treatment modalities.

(B) The treatment offered should:

(i) have a favorable risk/benefit ratio compared to other treatments for the same condition;

(ii) be based upon a reasonable expectation that it will result in a favorable patient outcome, including preventive practices; and

(iii) be based upon the expectation that a greater benefit for the same condition will be achieved than what can be expected with no treatment.

(4) Periodic Review of Treatment. The physician may use the treatment subject to documented periodic review of the patient's care by the physician at reasonable intervals. The physician shall evaluate the patient's progress under the treatment prescribed, ordered or administered, as well as any new information about etiology of the complaint in determining whether treatment objectives are being adequately met.

(5) Adequate Medical Records. In addition to those elements addressed in paragraph (1)(A) - (D) of this section, a physician implementing complementary and alternative therapies shall keep accurate and complete medical records to include:

(A) any diagnostic, therapeutic and laboratory results;

(B) the results of evaluations, consultations and referrals;

(C) treatments employed and their progress toward the stated objectives, expected outcomes, and goals of the treatment;

(D) the date, type, dosage, and quantity prescribed of any drug, supplement, or remedy used in the treatment plan;

(E) all patient instructions and agreements;

(F) periodic reviews;

(G) documentation of any communications with the patient's concurrent healthcare providers informing them of treatment plans.

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

There is a lot of verbiage here, and we can attempt to parse the various components (for example, what does it mean to “demonstrate the medical, scientific … principles” associated with a therapy?  What is in fact required?  Who must demonstrate what, to whom?).  The point is that physicians are now bound to observe these rules when they provide integrative medicine.

What’s a Functional Medicine Doctor to Do?

Is functional medicine, integrative medicine?

Some might say yes; others might say no.  This is in part a branding question, in part a clinical question, and in part a legal question.

To the point, should the functional medicine physician follows the rules governing integrative medicine, when their state actually says something these practices?

There are pros and cons.  Significantly, if a regulator or enforcement authority can find that the medical practice meets the statutory definition of Complementary and Alternative Medicine, above, then it doesn’t matter what the physician thinks.  If, in the eyes of the law, the MD is practicing “complementary and alternative medicine,” then it’s prudent to follow the rules expressed in the statute that relate to this practice.

And, bottom line, when drafting the Agreement between the physician and the patient or client, it may be prudent to mention or incorporate the above legal standards as they pertain to that clinical practice.

That may in some way shelter the medical doctor in the protection of the rule; at the same time, the rule imposes legal (and clinical) requirements on the physician, and the physician should acknowledge and honor those requirements.  Under the rule above, this means following the various parts of the rule related to:

  • Patient assessment
  • Disclosure
  • Treatment Plan
  • Periodic Review of Treatment
  • Medical Records
  • Therapeutic Validity

And appropriate language should go in the consent.

In some cases, it might be more appropriate not to invoke the umbrella of these rules—for example, if the proposed practice is one that could fall outside the definition of “complementary and alternative medicine.”

The decision as to what language to place, where, is often strategic, based on an understanding of what the physician actually proposes to do; the extent to which this follows more of the medical or coaching/information/education model; and whether the proposed approaches easily fit the integrative model or relevant statutory definition, or have professional and evidentiary support but nonetheless fall outside the familiar definitions of existing legal categories.  In these cases, experienced legal counsel can help craft suitable strategies for growing the medical practice and placing it on a firmer compliance ground.

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Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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