I once read a Facebook post in an integrative community group that asked members what natural “go-to” remedies were recommended to give her husband (who had been in an accident a few hours earlier, and was “showing signs” of a concussion). Floods of comments came through, giving dietary and supplement device, until finally an ER physician chimed in and said he needed to go to the emergency department. I don’t know the conclusion of the story (sorry!), but many of these practitioners who were giving dietary/supplement device had actually gone through conventional medical training!
Why do I mention this? If you are a conventionally trained practitioner getting into functional medicine, you cannot forget your classical training - it can get you in trouble legally. In fact, one of the many reasons that practitioners don't pursue functional/integrative medicine is because of legal worries. Let's consider the reason for legal guidelines, such as standard of care guidelines - these are in place to protect patients and to make sure practitioners are practicing safe medicine. Unfortunately, these are not well-defined, and ultimately it is the jury that makes the decision on a case if it goes to court (and they are the least qualified group to make such a decision!).
When you have a license (e.g. a medical board with an overseeing/regulatory state board), and you choose to utilize functional medicine concepts, there is risk that your practice will be perceived as “going against the standard of care”. Just because we don’t use as many risky pharmaceutical treatments or procedures does not mean we are held to a lower standard of care. Supplements and "alternative" tools have risk as well, even if that risk is simply that the patient chooses these treatments over pharmaceuticals.
“The mere fact that the [physician] may use a different approach is not considered a deviation from the recognized standard of medical care... Medicine is an inexact science, and generally qualified physicians may differ as to what constitutes a preferable course of treatment... Our law says that a physician is not an insurer of health, and a physician is not required to guarantee results. He undertakes only to meet the standard of skill possessed generally by others practicing in his field under similar circumstances.” (from article linked below, The Standard of Care: Legal History and Definitions: the Bad and Good News)
Standard of Care
A colleague once pointed out that when we practice functional or integrative medicine, to avoid "negligence" and legal troubles, there are 2 things that require more diligence when it pertains to functional/integrative medical practitioners, and neither needs to be a barrier that keeps us from practicing in the medical model in which we believe. These are:
- Putting a patient in harm’s way as a direct (and even indirect) result of your medical care.
- Going against the standard of care (i.e. “breach of duty”)
I will not dive too deeply into the first point, since I think we are less likely to “break” this rule as long as we remember our education - i.e. KNOW and UNDERSTAND the risks for any course of treatment or approach to disease.
The second point, however, is likely to occur often in practice, and as a result we must understand this to the best of our abilities in order to avoid legal consequences.
So what - or who - determines the standard of care?
Without going into legal language too much (you can read more about the legal “stuff” in the resource links below), the standard of care is basically a set of “guidelines” that ensure jurors understand what is a typical recommended course of treatment in a clinical practice, for a particular medical diagnoses/treatment. These guidelines are intended to show that a physician (or other health care provider, aka “HCP”) in a particular practice is not expected to know everything but must practice in a way that is similar to their peers in that particular specialty (which is an ambiguous statement). It also gives jurors a better understanding of how a HCP determines patient care.
In the legal system, the goal of all laws is to increase certainty and clarity, and for this reason the concept of standard of care is likely to evolve and change as legal theory develops on this topic. But for now, the current definition of standard of care encompasses the following:
- What a minimally competent physician in the same field would do in the same situation, with the same resources
- Bad outcomes are expected, but all entities cannot be expected to be diagnosed
- Clinical practice guidelines (CPGs) are what are used in court to support the standard of care, but these are always changing and their acceptance is decided on by a case-by-case basis (and updated yearly)
Based on my extensive reading of this topic (reading legal language is like reading a foreign language!), the best tips I can recommend for licensed health care practitioners - no matter what speciality or philosophy you follow - are as follows:
- Utilize a detailed, strong, physician-patient agreement that includes informed consent (written with legal/protective language). Patient must voluntarily choose their health path, but be able to do so with awareness of multiple options for care so he/she can make intelligent decisions with regards to care.
- Look up the most recent “standard of care” clinical practice guidelines (CPGs) for your speciality. These are updated every year. Here’s the link for family practitioners (2018 guidelines).
- If you know you will likely deviate from the CPG, gather 3+ reputable medical journal articles and/or write down the pros/cons of the treatment options you will be recommending. I'd even recommend finding evidence against the treatment option, in case this is ever brought up in a case. Unfortunately, even in conventional medicine, there will never be a publication that is incontrovertible and the definitive source of evidence for a standard of care document.
- I know it can’t be said enough, but DOCUMENT, DOCUMENT, DOCUMENT.
- I like to create a template in the EMR, with a phrase such as "patient given option for treatment, including use of pharmacological treatments such as ______; after discussion, patient chooses to refuse pharmaceutical management at this time and pursue modification of diet and lifestyle, with consideration of nutraceuticals. Patient understands the risks/benefits of each treatment option."
- In your documentation, list the reasons behind your choices (to establish credibility with your choices and show you thought about the options and gave well-informed suggestions to your patients).
- When you hear “standard of care”, think “what would my conventional medical colleagues do?” Again, mention this in an EMR template (if available), to "CYA".
Just as in conventional medicine, your services must be legally defensible. Unfortunately, this requires more work on your end, since functional/integrative medicine is not fully adopted by the mainstream medical community. If you follow the aforementioned suggestions, you build a good defense against potential future legal action.
In summary, don’t let legal language and concepts stop you from stepping out of the box of conventional medicine. But just as with any medical practice, if we fail to give informed consent or document thoroughly, this will always be a form of negligence and medical malpractice. The biggest risk, in my honest opinion, is that we stray too far from our knowledge of acute treatment options in favor of choosing “natural” alternatives. Or even swapping out pharmaceuticals with just as many, if not more, nutraceuticals. When we have conventional medical training in our education background, we cannot forget it!
For more information, check out these resources:
- Standard of Care and Risk Management: https://michaelhcohen.com/2018/02/integrative-medicine-legal-standards-drive-physicians-risk-management-practices/
- The Elusive Standard of Care (analysis and commentary): http://jaapl.org/content/jaapl/45/3/358.full.pdf
- The Standard of Care: Legal History and Definitions: the Bad and Good News: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088386/
- Legal tips for setting up a functional medicine practice: https://www.integrativepractitioner.com/whats-new/all-news/five-legal-tips-setting-functional-medicine-practice/
- Page 16-19 of this document (article written by a physician assistant and lecturer on medicolegal topics).
- Dr. Michael Cohen's (one of the most known attorney's that are familiar with integrative/functional medicine laws) new book: Your Healthcare Company's Legal Adventure: Legal Strategies and Solutions Health and Wellness Ventures Can Profitably Deploy (published 2018).
Disclaimer: This article is researched and written by a medical professional, and should in no way be considered legal advice. Please seek the advice of an attorney/lawyer before implementing any of the above recommendations in your clinical practice.