Hello. Good morning. Good day. Good afternoon. Buenos Dias. Shalom. Wherever you are. I’m Michael H. Cohen, a healthcare and FDA lawyer. Today’s topic is how can functional and integrative medicine doctors practice without undue fear of legal jeopardy?
Now that’s a long sentence. I’m a lawyer. You’ll notice I didn’t say without fear. I said without undue fear. There are lots of things that one can be afraid of in this world and it’s certainly legal jeopardy is one of them. We don’t want to be so afraid that we just don’t make a move. As always, it’s good to have legal counsel at your back, especially once you get into this kind of area. Let me see if I can set your mind at ease by going through a couple of topics.
See our prior blog posts:
WHEN ESTABLISHING YOUR FUNCTIONAL MEDICINE PRACTICE, YOU’LL BE WADING INTO CLINICAL WATERS THAT ARE OFTEN NAVIGATED BY MANY MEDICAL COLLEAGUES, YET NOT NECESSARILY ADOPTED WITHIN THE MAINSTREAM […]
Michael H. Cohen has pioneered the field of legal issues in integrative health. He served as Assistant Professor of Medicine at Harvard Medical School and Adjunct faculty at Harvard School of […]
Let me start with a story.
Just the other day a medical doctor called me and he’s affiliated with a hospital somewhere. That’s his day job. His contract is going to end in six months and he wants to know can he launch his functional medicine practice? Should he launch his functional integrative medicine practice?
A lot of times people call, they’re looking for advice, and sometimes it’s very, very specific advice. Other times I get this sense that underlying everything there’s kind of a gestalt of is this feasible? Feasibility analysis or can I really do this? Sometimes it’s, “Can you give me the support, the nudge, so that I can go ahead and really live my passion, live my dream?” Which a lot of people don’t do because they have undue fear.
Let me talk about a couple of legal issues that we’re critical to him, in a critical, and my view, is to how you assess the legal and regulatory landscape out there. When you’re a medical doctor or DO, a physician, launching into a branded customized functional medicine or integrative medicine practice, the kind of practice that is more fulfilling to you perhaps than what I now call cookbook medicine.
We could call it conventional medicine. I have academic tomes on conventional biomedical versus non-conventional versus complimentary and alternative versus integrative. Now it’s functional. They are somehow related and yet interconnected. We have a whole lexicon here of things that people want to do to practice healthcare with a medical license in the way that they find meaningful, valuable, and a great help to their patients.
See our prior blog post:
Many physicians, chiropractors, and other healthcare practitioners are wanting to start a cash-based, concierge or functional medicine practice yet not run afoul of legal and regulatory issues
I asked this particular physician why he’s so drawn to functional medicine. Well, a couple of reasons. Number one, it helps with his patients. I asked him to give me some examples. We talked in depth about nutritional genomics and how it might make a particular patient, say, more or less susceptible to certain diseases and also more or less susceptible to perhaps remarkably able to benefit from certain nutritional pathways that are customized for them.
We talked about the marketing, we talked about the business structure. We talk about creating programs, customizing the package. This was all part of the one hour legal strategy session because he really needed to be positioned to know that in fact he could launch. When we came to the nitty gritty legal issues the very first thing that we bumped up against was this question, is the standard of care?
Kudos to integrative medicine consultant Glenn Sabin for his bold post on integrative medicine standard of care – suggesting that integrative health should be the standard against which […]
Now in the old days … I know I still look youthful because I exercised today and oxygenated. Thank you very much. The reality is that I was part of a wave some number of years ago of clinicians with clinicians, I’m not a clinician but with clinicians, around the country during my faculty position at Harvard Medical School where I was in the division for research and education in complementary and integrative medical therapies.
During that time I sat on quite a few policy committees and I gave talks, I gave CME talks, I gave other talks, and there would be some … I want to say curmudgeonly but I want to be a little cautious.
There would be some representative of some formal government agency or medical society and they would be saying, “Well, this is all a bunch of bunk. There’s no evidence for it. This is all very dangerous. We have to shut it down.” Meanwhile, of course, more and more popular with patients. More and more evidence-based movements within the academic medical centers of Harvard, Duke, Columbia, Stanford, Georgetown, Yale. It just goes on and on and on.
We fought these battles and I call this the era of war by epithet. In other words, they would just call certain doctors a name in the medical journals and it was kind of like the old word quack. I know there I’ve said it, the Q word. Can’t say that word anymore in public but that was the landscape.
We fought these battles and I ended up publishing over 100 articles in law journals and peer-reviewed medical journals and books all to try and change the language, the lexicon, the verbal landscape of a different kind of medicine so that we could create more freedom, more spaciousness, a greater awareness, and more and more freedom to have these different pathways to health and recovery.
These battles were fought. Many of you fought them. Many of you were involved in clinical trials and research and there’s a good hefty chunk of evidence out there. I think that becoming a standard of care a lot of those battles have been fought. You just don’t have the same level of rampant fear and mentality that you had with the medical boards where anything that was not 100% ultra-orthodox, uber orthodox, super conventional, would immediately become suspect.
In the early days you would have disciplinary investigations arising simply out of the fact that a physician was so inclined to try what we could characterize as clinical innovation. A lot of those battles have been fought. When you’re talking about nutritional genomics and things for which there is a good emerging, growing basis of evidence of medical literature, understand that I consider this an emerging standard of care. That you’re no longer naked in the way that you would have been even, let’s say, 10, maybe 15 years ago, when these battles were being waged on a daily basis.
Now of course be sure that you’ve got a good standard of evidence and understand from the legal doctrinal point of view that there is a doctrine or rule known as the respectable minority. The idea is that it is not necessarily medical malpractice to introduce clinical innovation so long as there is a body of evidence supporting the therapeutic treatment and that there is a respectable minority of physicians that agree that this is a beneficial approach.
See our prior blog post:
INTEGRATIVE MEDICINE ADVERTISING LEGAL REVIEW: DOES A FLYER NEED LEGAL REVIEW OR JUST “WORDSMITHING?”
Integrative medicine advertising legal review: does a flyer need legal review or just “wordsmithing?”
If you want to understand more about this you can read my books, you can go to the blog at https://cohenhealthcarelaw.com. I drill down in much more depth and detail than I can in this short video about standard of care, the respectable minority defense, understanding medical malpractice in light of evolving standards of care, and in light of integrative and functional medicine and so on.
For the moment, understand the flavor is that there is a wind at your back now and it’s growing and growing, especially the more that you have medical groups, medical societies, organizations jumping in to anti-aging medicine, functional medicine, integrative medicine, complementary medicine, longevity medicine, health and wellness, both nationally and internationally.
The second legal issue that we came to was informed consent. Everybody knows about informed consent. It’s the patient’s right to autonomously determine what will be done with their own body. As beautifully articulated by Justice Cardozo in a very early case.
Of course, if anyone is ever a patient and goes to the hospital you’ll fill out these long, scary, detailed informed consent forms detailing every possible thing that could go wrong and then you sign it and then try to meditate it all away and surround the [inaudible 00:08:03] positive energy. Maybe get your healing visualization tapes. You’ve got the law going in one direction and maybe consciousness ascending in a different direction. Somewhere the twain meet and we have to meet the informed consent obligation.
Informed consent is critical in all areas of medicine; it takes on added importance with integrative medicine, functional medicine, anti-aging and aesthetic medicine, and non-mainstream […]
The point, though, is that if you’re going to be practicing in a very specialized mode, let’s say, that in this physician’s case, he did not want to take responsibility for every single facet of the patient’s treatment process, of guiding the patient through the disease back through the various stages. In particular, he was just tired of medication management. Just tired of medicating patients and adjusting dosages and dealing with that.
The idea is that any informed consent form what he would do is really carefully we would craft his role as that of a specialist. He would disclaim primary care. He would disclaim medication management. Now this has several advantages from a legal protection prospective.
Number one, you’re being eminently clear about the relationship and the agreement that you want to have with a patient. You’re being very clear in terms of what kind of care you’re going to provide. You’re really manifesting a mutual assent that the relationship and the kind of care that’s been given are going to fall along certain lines.
You’re also disclaiming certain kind of care that you don’t want to take responsibility for. A seminal decision is whether you want to agree to provide primary care or disclaim and say that it’s going to be something that you’re not providing. That’s an important link for this kind of practice.
Now next in terms of medical malpractice I would just say there’s an insurance piece here, which is it’s important to go to your insurance company or your insurance broker and see whether you’re actually covered for liability if you’re practicing in a functional medicine or in an integrative medicine vein.
It would be really great if you could get confirmation from your insurer that the exact approaches, programs, therapeutic modalities that you plan to offer are indeed covered under your malpractice liability policy. If they’re not, perhaps you need a rider. At any rate, don’t go uncovered. Make sure that there’s coverage. Do whatever you can to inform your insurer and to have two-way communication so you know how you’re going to be positioned if indeed there is a claim.
Just a side note here, standard of care has to do with malpractice but really my concern on this side is more about a disciplinary investigation from the state medical board as opposed to something that actually results from an injury to the patient. The medical malpractice claim from a patient is potentially covered by insurance or potentially settled. You definitely have to show an injury. There has to be causation.
On the other hand, if you have an inquiry from the state medical board this can be very time consuming. This can be very draining. This can be emotionally very weighty. It can threaten and jeopardize your license. We don’t want that. That’s why I focused more on the standard of care from a disciplinary perspective.
Now there’s a topic that I’m not going to cover today and that has to do with the insurance aspect of insurance coverage for the patient. Medicare coverage or any coverage by third-party commercial insurance. I address those topics both on the blog at https://cohenhealthcarelaw.com. You just go to the blog, you can put in the search bar insurance or Medicare or reimbursement.
You can get a whole world of article and we also have courses that we offer. You can find those again on our website. There is a course specifically devoted to the issue of how to navigate Medicare insurance, commercial insurance, and it gives very practical advice. You can find that material there.
Okay. To recap, today we’ve talked about standard of care, informed consent, medical malpractice, liability, and trying to be sure that you have the requisite coverage from your insurance. I mentioned a little bit about Medicaid and third-party reimbursement.
Those are the key topics that this physician had to address in order to launch himself away from his hospital and into the kind of practice that he would ideally like to design. There were some other issues. For example, there’s always contract review. We wanted to review his contract with the hospital. There is some non-compete language in there. Some of that can be artfully negotiated.
There are strategies for having ineffective negotiation with the hospital. Remember, that you have a lawyer on this video that is on your side and when you’re negotiating with the hospital you’ve got hospital counsel on the other side. Not to over-generalize but they tend to not be the most flexible of groups. They see risks everywhere. Talk about risk mitigation and undue fear.
You’ve got a bit of a steep uphill climb to go in terms of dealing with hospital counsel most of the time. That’s something where your attorney can help you negotiate the process and can also give you pointers on dealing at a business level with your counterparts, your supervisors in the hospital system, so you can get some traction.
Let me close with this. We started talking about undue fear and this particular client had actually undergone a lot recently. His other interest in functional medicine besides its efficacy with his patient population was the way that it had helped him recover from a very, very deadly and debilitating and degenerative chronic disease.
He had successfully used nutritional interventions, targeted, and focused, gnomically intense nutritional interventions, specific lifestyle choices, impeccable advice from his functional medicine physician plus what he had learned with respect to specific pathways. He had just gotten incredible results.
This is what he wants to do in life. He’s also at an age where he’s been practicing for years and years. He doesn’t want to just keep showing up day after day treating volume, as he called it. That’s what his hospital wants. They want volume. They want him to see as many people as possible, get them through the system. Of course, get the good outcomes so they can get the good reviews and whatever financial incentives the government might afford.
Also, they want him to move people through the system. After a while, that became a drain on his soul. That became a real burden. It was contributing to his emotional and physical and spiritual exhaustion. He really needs to get over this little non-compete that may not be enforceable or legal anyway. He really needs to have the wind at his back, the confidence, the legal support, the legal confidence with respect to these issues, standard of care, disclaiming primary care, informed consent, insurance issues so that he can go and launch his dream practice.
This is important. This is really meaningful to him at this stage in life. He can’t put this on the shelf and forget about it. This is his dream. This is what he’s going to do with the rest of his life. He can’t not bring functional medicine to his patients. He has the knowledge. He’s got the fire of the gods. He’s going to deliver to humankind.
My role as his attorney is to help him. My role as an attorney is to help him stay out of undue risk. Now attorneys we’re very good at being pessimists. We excel at seeing the worst that could happen. We have x-ray vision for risk mitigation. We have a Spidey sense that is highly developed. We’re also gifted at wordplay. This lifetime it isn’t swordplay. It’s wordplay.
As Shakespeare said, the pen is mightier than the sword. That’s our gift. I devoted in service to my clients to help push them through the obstacles that are out there. Not in an aggressive way. This is not Conan the Barbarian. Maybe I’m betraying my age here with the reference. It’s a gentle nudge and it’s realistically looking at the legal obstacles and coming up with strategies to address them, to overcome them where we can, and to give this particular physician the confidence, the energy, and the sense of pride in his knowledge and the gift that he can bring the patients so that he can move to the next level in his life and in his professional practice.
Thanks for being here. If you have more questions please reach out at https://cohenhealthcarelaw.com We’d love to speak with you. Have a wonderful day.