In any medical encounter, it is always a good idea to actively seek a patient’s informed consent, especially when significant risks are involved. When complementary or alternative medicine is involved, it becomes all the more important. For physicians practicing integrative medicine, properly written and executed informed consent forms are essential for preventing potential legal problems.
The informed consent process not only ensures that patients have an opportunity to weigh the risks and benefits of a particular CAM approach, it also places the patient on notice that a specific treatment is considered nonstandard and outside the “cookbook” of conventional allopathic practice. Many courts, state medical boards and regulators fail to distinguish between nonstandard care and substandard care, so integrative practitioners face unique legal risks. But this can be greatly reduced by a rigorous informed consent process.
Regulators scrutinizing CAM practice usually claim “consumer protection” as their prime motive. An informed consent form is evidence that a consumer has voluntarily chosen a nonstandard approach, with clear knowledge of its status vis a vis mainstream medicine, its potential risks and benefits, and what mainstream therapies he may be declining. Prosecutors and regulators are less inclined to move against doctors who can demonstrate that patients are engaged in a rational, informed decision-making process.
A Valuable Document
Though prosecution is rare, failure to obtain informed consent prior to a procedure is in itself a civil cause of action¾a treatment not consented to can be seen as a form of battery or unlawful touching. A civil plaintiff can bring this claim along with a claim of negligence. Informed consent in its narrowest sense is a solution to this concern.
In some states, a consent requirement is an overtly stated policy with regard to CAM. In Maryland, for example, CAM is considered more acceptable if informed consent fully discloses the nature of the services. In any state, it is more difficult for a board to demonstrate unprofessional conduct or breach of standards if a patient understands that a treatment is non-conventional and has stated in writing that it was his or her wish to engage these services.
This will not be protective in cases where a board believes a certain therapy poses inordinate risks. Some boards will move against therapies they believe are outright quackery. But signed consent always limits administrative risk to some degree.
Types of Informed Consent
The most common types of consent forms are for specific therapies or procedures: IV practices like vitamin infusions, chelation, H2O2, Insulin Potentiation Therapy or Colchicine; Unusual techniques, such as prolotherapy, electroacupuncture by Vole (EAV) and DMPS challenge testing; Nonstandard approaches to a specific disease, such as alternative approaches to cancer treatment or Lyme disease.
A self-audit of your practice’s legal exposure should include a full inventory of all practices and techniques. Those outside mainstream standards of care and those that present either intrinsic interventional risk or indirect risk through avoidance of conventional treatment should definitely be covered by informed consent forms.
Limiting Risk with Well-Written Forms
A consent form can also require a patient to declare that he or she is there for his or her own purposes and not on behalf of a third-party. This will discourage undercover board investigators, or at least diminish their credibility if they agree to sign it.
A critical but underutilized strategy is to define and limit the role of the practitioner. Physicians who intend to act as “specialists” and do not function as primary care are well served by having patients sign notices acknowledging this role. This can shut down a malpractice case if the claim is based on an assumption that the doctor has taken broad responsibilities for the patient¾for example, failure to diagnose a problem other than the one for which the physician was providing a specific CAM treatment.
Given the holistic nature of integrative practice, the relationship can easily wander into broader responsibility for patient care, even if this is not the intention of either the patient or the doctor. A form clearly defining the relationship helps limit presumed responsibilities. This is not a consent form per se; rather it is a statement of the scope and limits of responsibility, and documentation that the patient acknowledges this limit.
For clinics involving independent contractors or multiple practitioners who rent space, an informed consent form can be used to notify patients of these arrangements, thus reducing risk that the clinic itself would be named in a suit if one of its leasees or contractors was sued for an alleged mistake.
Be aware that informed consent doesn't necessarily require a signed form, and that a signed form does not necessarily mean informed consent was given.
For therapies where there is no significant risk, its acceptable to write in the patient’s chart that the risks¾however minimal¾were discussed, and the patient accepted them. You can also note particular treatment decisions, for example: “Discussed risks and benefits of statins with patient, who declined, and wants to explore other options.” Always document a patient’s decision to decline conventional treatment or referral for conventional care. For routine CAM procedures, it is a good idea to have written forms.
Rather than seeing informed consent as an unwelcome task, approach it as part of the patient education process. That is, in fact, its legally mandated raison d’etre.
To be fully effective, consent forms must be signed after discussion between practitioner and patient; they are intended to document that conversation. Do not simply hand a patient a stack of forms to sign¾ as part of “getting the paperwork done” ¾before you’ve discussed the particular treatment. The law views this boilerplate approach to be a “contract of adhesion,” a signature the patient must give in order to get services without any informed discussion. This is the antithesis of true informed consent and is not considered legally effective by courts or boards.
That said, all intake forms should include a generic consent known as an “authorization to treat,” and it should indicate that your practice incorporates CAM methods. It should include insurance notices and bind financial responsibility should an insurer conclude that the treatment is medically unnecessary. Financial notices must be specific to your practice’s policy with regard to Medicare & private payors, billing practices, response to insurer requests, and so forth.
Common Problems & Hot Spots
A common tendency when drafting consent forms is to underplay risks, leaving out items that might scare patients (ie., risk of anaphylactic shock from an injection). If a risk is not listed, then there is no legal protection should that risk materialize. Its absence from the form is, in fact, evidence that the patient was not fully warned about risk. It is acceptable to give accurate assessments of risk (ie., stating that anaphylactic shock is a highly unlikely risk from injection), but omitting potential risks is not a good idea.
Be aware that informed consent forms will not protect against charges of illegal practice of medicine by non-physicians. Consent forms must always be in accord with all scope of practice laws pertaining to you as a physician and any non-physician practitioners working in your clinic. Some forms in circulation declare a right to the “health care of one's choice,” under the Ninth Amendment. Such statements should be avoided. They are untrue and act as an admission that the care in question is out-of-bounds.
Another common clause is one in which the patient waives the right to sue. This language will be thrown out, as running clearly against public policy. Such a clause makes the doctor appear defensive and suspect. Another common mistake is to declare that a therapy is under investigation and that the doctor is conducting research. Only make this statement if you are in fact a clinical investigator doing legitimate research.
Anatomy of a Consent Form: Phosphatidylcholine Push
CAM consent forms vary in length; the longest one I provide is a chelation form that runs over 8 pages. Others are brief. This is the actual language of a consent form for phosphatidylcholine IV push. It shows the basic components that should be included in any consent form.
The first component is a Brief Description of the Treatment, including what to expect:
Phosphatidylcholine is an essential component of lipid metabolism. A small amount of blood will be withdrawn into a syringe containing the medication, mixed, and then reinjected over a period of about five minutes as an intravenous push.
Follow this with a statement that the treatment is not accepted by mainstream medicine, the FDA, or other relevant regulatory agencies:
While the value of phosphatidylcholine in the diet has been noted in scientific monographs, its value is not expressly recognized by the United States Food and Drug Administration (FDA) and its use in medical treatment, either orally or by intravenous injection, is considered nonstandard treatment by the medical community with the exception of some physicians who practice integrative, functional or nutritional medicine.
Then include any Patient Instructions, which might be about vitamins they need to take or substances to avoid:
PLEASE NOTE: Phosphatidylcholine is derived from soy. If you have allergic reactions to either soy or peanuts, you should discuss this with your physician before receiving treatment.
List Potential Risks, Adverse Reactions and Contraindications:
Like any treatment, infusion therapy carries some risk of side effects. While adverse events are unusual, I understand that I could experience side effects, some of which are common such as discomfort at the infusion site or temporary bruising. Temporary discoloration and slight blistering may occur at the site of injection; all usually heal quickly. Thrombophlebitis, an inflamation of the vein, may also occur and could require treatment such as hot packs and bed rest. Sometimes blood may become trapped at the injection site; this is an anticipated occurrence and can easily be removed by your practitioner. Infection is also a remote possibility with any invasive procedure.
While phosphatidylcholine is a natural substance that is nontoxic, all treatment substances pose some risk of allergic reactions. Allergic reactions to the infusion substances are unusual and are usually restricted to the injection site. Some patients may experience itching, hives or light-headedness. In extremely rare cases, there have been isolated reports of severe allergic reactions causing respiratory, cardiovascular distress or even death. Fortunately, these extreme reactions are rare. In infrequent cases, there may be a reaction to the benzyl alcohol content of the infusion.
Indicate the discussion of Other Treatment Options:
In addition to discussing other modes of therapy that may be used for the treatment of my condition, my physician and I have discussed and I understand the possibility of a referral to a specialist in my condition(s) if I have not already consulted with an appropriate specialist.
Follow this with a statement that there are No Guarantees of a Good Outcome:
I understand that, as with any health treatment, there is no guarantee that I will obtain satisfactory results. If I am being treated for a medical condition, or have symptoms which suggest a medical condition may be present, I have been informed that it is in my best interest to discuss potential alternative methods of treatment for my condition with my primary care physician or an appropriate specialist before as well as during the course of treatments. I understand the use of this procedure does not preclude me from using other treatments as well, though I recognize that I should inform any practitioners I am seeing about the various treatments I am using.
Provide notice that Insurers are unlikely to pay and reiterate financial responsibility even if the insurance company declares the service “not medically necessary.”
Insurance companies are likely to consider this therapy to be non-covered as an experimental therapy, or to deny claims for this therapy as non-standard care or as not medically necessary. I understand that I am financially responsible for this therapy even if my insurer denies the claim for any reason.
Close with a Statement of Consent to be executed by the patient:
I hereby consent to phosphatidylcholine therapy and certify that I understand the nature of this treatment, including the risks of possible complications and choices I may have about other approaches, and I assume those risks about which I have been informed. I have been adequately informed, and questions I have asked have been satisfactorily answered. I represent that I am seeking treatment in order to further my own health and for no other reason and do not represent a third party. I am aware that I may withdraw this consent and stop treatment at any time.