Recently, a physician contacted our healthcare law office about setting up his own Functional Medicine practice. Let’s call him Seymour Heart. (This is poetic license, borrowing from the name Seymour Glass. Hint: J.D. Salinger.)
Dr. Heart was working in a large, multi-specialty medical group. He planned to start as a sole physician and eventually grow into a multidisciplinary, integrative care medical clinic with chiropractors, acupuncturists, massage therapists, and a Reiki practitioner. With a background in Functional and Integrative Medicine, he wanted to spread his wings beyond the clinical constraints of a restrictive clinical environment.
He asked for input on a variety of legal issues:
- Drafting consent forms appropriate to a Functional Medicine practice
- Helping him navigate telemedicine issues
- Advising on liability and risk management issues
- Discussing how to handle his Medicare and commercial insurance obligations
- Handling a host of related legal and regulatory issues
We’ll address some of these topics in this and subsequent posts. Of course, we’ve changed the facts and anonymized client details to provide some legal tips below.
1. Understanding and Documenting Evolving Standards of Care
Challenge: Standard of Care
Because Functional Medicine is not fully adopted by the medical community at this time, and integrative health care in general steps outside conventional practice, we want to ensure that any therapies or modalities offered are as legally defensible as possible.
As a first step, this means paying attention to standard of care issues. Yet what is the standard of care in Functional Medicine? Is it the same as in conventional care?
The law isn’t very clear in the answers to these questions, however, because Functional Medicine is a relatively recent development in medicine, particularly when considering that medical licensing laws date back to the late 18th century. Hence, technology, industry, and science outpace the more glacial path for the legal framework underlying health care. While this is the way of the industry, it nevertheless creates a lot of confusion when legal rules are ambiguous or anachronistic. Yet practitioners want to advance. How do Functional Medicine clinicians navigate this terrain?
Many lawyers are trained to say “no.” However, their answers are more nuanced than a dichotomous, black-and-white yes or no. There are times to ask for permission, times to ask for forgiveness, and times to step forward mindfully while understanding the perils and pitfalls.
The key concept here is risk mitigation. In other words, making practices more legally defensible is a matter of understanding and minding the applicable rules while giving room for innovation.
Lawyers aren’t pessimists by nature. (I speak from experience—remember that my fictional client is called Dr. Seymour Heart.) However, we are trained to detect risk and identify strategies to mitigate risk. It takes a very sensitive nose for when those dizzying legal eddies try to suck a clinician down. We sniff out danger zones and give preventative advice to try to avert unwarranted regulatory scrutiny or investigation.
Good legal detection, which we call “issue-spotting,” can result in very practical advice. For example, always consider standard of care issues. In terms of standard of care, the law overall might be underdeveloped in emerging practice areas such as Functional Medicine. Additionally, when a physician steps out beyond cookbook, conventional medicine, risk always exists that someone will object on the ground of standard of care—even if the therapeutic approach turns out to benefit the patient! As an important risk mitigation strategy, we can document the therapeutic reasoning behind a particular approach.
In general, the more research and clinical groundwork devoted to Functional and Integrative Medicine, the more we will see an evolving standard of care. We all know that standard of care is, essentially, established by the medical profession, and that means your peers. If those particular peers on a medical board panel are ideologically opposed to a systems approach, then an expert with negative bias could see fault where none exists. However, if those same physicians can see the logic, wisdom, vision, and evidence behind a Functional Medicine approach, then legal results should flow accordingly.
For this reason, we recommended that Dr. Heart evaluate the range of therapeutic approaches in his therapeutic arsenal and create a back-pocket list of scientific references, which provides the medical evidence to justify those approaches. Put another way, documenting the therapeutic reasons behind a particular choice can help establish that thoughtful, well-informed medical decision-making was in play.
This is essentially the approach taken by the Federation of State Medical Boards in its Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice. While these guidelines were developed for complementary and alternative medicine (CAM) therapies, generally, they also apply to Functional Medicine.
Dr. Heart responded by establishing in his files that the therapeutic approaches he uses have validity and are not less safe or less effective than the corresponding, conventional approach. Consequently, he lowered his legal risk, and he felt relieved and better about his practice as well.
2. Providing Robust Informed Consent
Challenge: Informed Consent
There are two different bases for malpractice liability. The first is negligence, which is defined as providing care below the standard of care, that leads to patient injury. The second is a failure of informed consent.
Informed consent is a process and a practice that can be documented by a clearly written informed consent form.
Best practices and good legal risk mitigation include drafting an informed consent form that describes the major risks, benefits, and alternatives of a Functional Medicine approach.
We recommended that legal counsel review and appropriately modify Dr. Heart’s informed consent forms to accommodate his Functional Medicine practice. We also included specific language to bolster potential legal protection for Dr. Heart, such as language providing for arbitration, language addressing his recommendations involving dietary supplements, and perhaps most importantly, language clarifying whether he would be acting in the role of a primary care physician. With his input, we added statements to disclaim the primary care role and to note that he would be focusing on overall wellness, taking clinical paths other than addressing symptoms of the underlying disease.
3. Contributing to a “Respectable Minority”
Challenge: Conventional Models of Clinical Care
One of the defenses to medical malpractice is that a “respectable minority” exists within the medical profession that adopts a particular therapeutic approach. In other words, because medicine allows for clinical innovation, a clinician should not be subject to a malpractice verdict (or to medical board enforcement) merely because the approach is not cookbook, conventional medicine—so long as a respectable minority that follows the approach exists.
Functional Medicine arguably has garnered the status not only of a respectable minority but has moved beyond in terms of gathering professional support. The more that Functional Medicine practitioners contribute to clinical practice and to the body of literature and evidence and professional support for Functional Medicine approaches, the greater the “stickiness,” if you will, of this respectable minority defense. It’s like a legal ledge, a safe harbor in the tidal waters of liability and enforcement exposure.
We recommended that Dr. Heart follow the approach outlined in the guidelines by the Federation of State Medical Boards and apply it to his Functional Medicine practice. The Federation suggests that the clinician have a favorable risk/benefit ratio for the Functional Medicine approach, a reasonable expectation that the approach will result in a favorable patient outcome, and an expectation that a greater benefit will be achieved than that which can be expected with no treatment. Furthermore, practitioners should keep accurate and complete medical records to document the approach and should periodically review the patient’s progress. The Federation also states that physicians “must be able to demonstrate a basic understanding of the medical scientific knowledge connected with any method they are offering or using in their medical practices”—and we would add here, “with respect to Functional Medicine.”
If as a clinician, you think of this in terms of a paradigm shift, the logic of the respectable minority defense is really similar to the way Thomas S. Kuhn posed the nature of an intellectual revolution: the new paradigm is first reviled and then slowly adopted and then enthusiastically embraced with a sudden shift.
About Michael H. Cohen
You can learn more from Michael H. Cohen, JD, MBA, about legal issues inside the Legal Module of “My Practice Plan,” a 16-week, online business management course specifically designed for Functional Medicine practitioners to build, grow, or reinvent their practices. Students of this course will come away with a personalized business plan based on their desired business model as well as insights into legal matters, including telemedicine, informed consent, HIPAA/privacy, and other laws, and how these laws can affect a Functional Medicine practice.