Functional Medicine Legal Issues
In today’s video, we discuss how functional medicine practices can navigate some of the legal traps that assail many medical practices and healthcare businesses, especially when they get into somewhat novel or unconventional waters such as functional medicine.
I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. All we do is healthcare and FDA law. I take supplements, I eat sauerkraut, I love prebiotics, I get my labs checked, I hug trees.
While I was on faculty at Harvard Medical School, for five whole years, I was a legal scholar who could advance the laws governing integrative medicine. My role included creating model policies and procedures that the 14 Harvard-affiliated hospitals could look to adopt, that would allow them to integrate evidence-based, complementary and alternative medical approaches into conventional care, including hospital care.
My mentor, a dual-Harvard-degreed physician—or “preparation H,” as he called it—encouraged me to be a dispassionate legal scholar.
I’m now back on civilian terrain, as an attorney and owner of a law firm, and since you know I eat sauerkraut and hug trees, I am allowed to be passionate again. I like functional medicine.
If you’re a medical doctor with a functional medicine practice, here are three things I’d like you to know about the legal landscape you’re facing. Once you know these three things, you’ll have tips and tools to help mitigate your overall legal and regulatory risk.
First: while I was at Harvard, functional medicine was just getting its sea-legs. Back then, we talked about the “respectable minority” defense to a medical malpractice claim. The idea is that even if the physician does something outside the general standard of care, it isn’t necessarily malpractice, if a respectable minority supports the therapeutic approach, as documented in the medical literature or as current practice among practitioners.
Back then, we could argue that functional medicine was starting to gain a respectable minority; but I would say now, there are many, many functional medicine doctors out there, there is a lot of peer-reviewed medical literature, functional medicine doctors are very data-driven, using lab test results, so I would say that I am less concerned about standard of care issues … unless of course, the facts and circumstances are very bizarre, unique, or somehow indicative of a therapeutic approach that is risky and a real outlier.
Second: it is challenging to combine a functional medicine practice with a concierge medicine approach. The big challenge is that Medicare covers many healthcare services, and if Medicare covers the service, then you cannot double-charge, so to speak, by including the healthcare service in a concierge model.
OF course, this isn’t the full story; we can and do advise our many functional medicine doctors on decisions such as opting out of Medicare, and also about other legal issues such as whether they can adopt a coaching model in states where they are not licensed. We do have resources on our blog, cohenhealthcarelaw.com/blog, and we do conduct a Legal Strategy Session, normally as a first step with our physician clients who want to explore these topics.
Third: we have talked in prior videos about the MSO model. The MSO model is one which separates the clinical, medical functions from the management and marketing. This is particularly useful if the functional medicine practice is part of a larger wellness center that embraces multidisciplinary approaches.
So, to sum up: first, understand that simply because you’re doing functional medicine, you’re less likely to have a malpractice risk than some years ago; but also know that outliers can stand out. Second, a concierge medicine approach is not impossible, but it does pose legal challenges. And third, the MSO model is potent in mitigating risks of corporate practice of medicine and fee-splitting violations, particularly in the multidisciplinary wellness center.
Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon. And by the way, sauerkraut is yummy!
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.