Healthcare lawyer and FDA lawyer, What’s the difference?

Hi, this is Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. I’d like to talk to you about some of the common questions that come up with our health and wellness industry clients.

Term Definition

The first thing I want to talk to you about is why we use the term healthcare lawyer and FDA lawyer. When it comes to the health and wellness industry, which is well over four trillion dollars at this point, there are so many questions that can come up. So many questions about the laws that pertain to healthcare itself. When we say Healthcare law, there’re really so many different areas of healthcare law. For example, most doctors, most physicians think only about medical malpractice. What happens if they get sued? What happens if there’s a claim?

Medical malpractice is actually a very small part of the market for legal services in medicine, let alone the health and wellness industry. In fact, for the medical malpractice liability risk, there is medical malpractice liability and most of the time, this doesn’t get triggered. In fact, the number or percentage of claims against primary care doctors are relatively low. So this is a risk that can be managed, it can be mitigated. We can also help our physician clients, our medical doctor clients, MDs or DOs, or even chiropractors, or even let’s say, advanced practice nurses or nurse practitioners that are on their own in liberal states, put in place measures to help mitigate liability risk, medical malpractice exposure mitigation risk managers. That’s a lot of nouns right there in a row, yet that’s what we do. We can help them with the risk mitigation.

Other issues are, for example, if you’re within the Medicare system, you don’t want to violate the Medicare rules. What happens if you do? Penalties, very steep per patient per violation penalties. They can really add up over time. Also, if you’re offering more of a concierge service, or a cash-based membership or subscription service, how do you design a battery of service offerings for your patients that are nonetheless not going to run afoul of Medicare’s prohibition against double-billing for Medicare-covered services? That’s another area that a lot of our physician clients have to deal with.

Yet another is how they deal with commercial insurance and designing a VIP, concierge, retail boutique, or membership or subscription model of practice. Yet another is how physicians, MDs and DOs will integrate their practice plan with other professionals, other clinicians, such as, for example, a DC, a chiropractor. How do you create a multidisciplinary health care clinic? What are the laws that apply to that, and the regulations that apply to that?

Healthcare law VS FDA law

The way that I break this down is really two parts, to keep it very simple. So first, there’s healthcare law, which applies to healthcare services in general, and then there’s FDA law and FTC law, which apply to health and wellness products. If you’re a doctor and you’re practicing medicine, you’re going to be under the health care laws of your state. For example, you’ll have a license from your state. The state medical board controls your licensure. What do you have to do to get licensed? What do you have to do to keep your license? What will get you into physician discipline, investigation, and possible loss of licensure, and therefore, what things are prohibited or what things are going to raise your risk profile, with regard to licensure and discipline?

If you are a physician, or a layperson, or a venture, a business, let’s say a healthcare business, and you’re promoting a product, be it a dietary supplement, a cosmetic, a medical device, a drug, a biological, a vaccine, a probiotic, a radiation emitting treatment, these are all going to be regulated by FDA, which regulates products in interstate commerce, almost everything is interstate commerce, to have a health and wellness flavor orientation dynamic to them. It’s important to classify exactly what that product is so you understand how the FDA can exercise its jurisdiction.

The Federal Trade Commission, FTC, controls advertising. It regulates. It prohibits false and misleading advertising. You’re going to want to get FTC review for your advertising marketing claims for health and wellness products. So very simply, there’s health and wellness services, health and wellness product.

As we said, within the arena of health and wellness products, we’ve talked about FDA, we’ve talked about FTC, we’ve talked about medical devices versus supplements versus cosmetics versus drugs versus OTC drugs as opposed to RX drugs, and so on. When it comes to services, we talked about medical malpractice, we talked about licensure and discipline, we talked about Medicare. There’s also HIPAA, privacy, and security, which can have state as well as federal dimensions. You can see that the list of potential areas of law that apply is mounting.

There’s pharmacy law, sometimes there’s telemedicine law as well, which is a variation on licensing law. There’s prohibitions against corporate practice of medicine, again, a variation against the unlawful and illegal unlicensed practice of medicine. So many areas.

Now, you have to be a specialist as a lawyer, to the extent that you understand these different areas of practice, and also, you also understand how these practice areas work together synergistically, to create the exact context so that you can unlock the puzzle.

Let’s talk about tessellation. The other day, I was at the museum with my son. Do any of you remember a barrel full of monkeys? Remember, you used to pick up the monkey, and then it would have an arm, and it would hook, and there’s another monkey, and basically, you would hook all these monkeys together from the barrel, you’d try to pick them up without dropping them. Well, there’s a new and improved version of that, and it’s a museum exhibit. They have these magnetic monkeys. You stick them up on the board, and the monkeys have a head, they have two arms, and then they have these legs, and what you’re supposed to do is you’re supposed to tessellate these monkeys. You have to figure out which of the monkey parts fit together. Like, a head goes in this little hole, and the arm goes in this one, and the leg goes in that way, and they can go upside down and sideways, and create lots of patterns and colors. Tessellation. My three and a half year old now knows a word that I had never heard of until yesterday, tessellation.

By the way, for my marketing ad, I’m going to get all these SEO clicks on tessellation. Folks, if you’re interested in tessellation, go contact your Ph.D. I’m talking about metaphors for law practice. I often talk about a Rubik’s cube. The point is, all these interlocking parts have to fit together. The tessellation exhibit asks a math challenge. What shape doesn’t tessellate? Just like that’s asked of a toddler, similarly, we’re asked that all the time. Like, does corporate practices of medicine change the way that we look at HIPAA, or are these things completely independent?

It takes a fairly sophisticated legal mind and years of experience to understand this exact problem because one of the fundamental things we do as healthcare lawyers and as FDA lawyers is we issue spot. So someone will come with a complicated set of facts. “Gee, I’m a physician. My husband is a businessman and he’s an IT guy, and he wants me to start a medical spa. Can we both be on the phone at the same time? Is there a conflict of interest? Does he need separate representation? He wants to do this, he wants me to be medical director.

“I honestly don’t plan on being there a lot because I love to play golf, and we want to offer these seven therapies and one of them just came in from Indonesia. It’s really cool, but I’m not sure if it’s legal, and oh, by the way, I want to buy this laser that only physicians can purchase, but I don’t want to finance it, so can he, as the MSO or medical management organization finance the laser, and can he provide a guarantee if I have to buy the laser, or can he even buy it? Gee, there’s an FDA issue. Is it a class two prescription medical device? I wonder if there’s an unlicensed practice of medicine issue there?

         “Is there somebody buying the device or using the device that is not authorized by law to use that medical device? That raises the question, who made the device? Is it FDA cleared? Medical devices don’t go through approval like drugs, so now there’s an advertising question. If you’re the physician, and you’re promoting this device, and all you did was simply copy the claims on your website that had been put into play by the manufacturer, and the manufacturer has never gotten an iota of legal trouble over these claims, are you now legally responsible for the claims on your website, and could FDA or FTC, or the district attorney, or the attorney general, or some other hot-blooded prosecutor come after you for false and misleading advertising based on the claims that you’ve made for a product where all you’ve done is copy those claims from your manufacturer’s website?”

That is a very long, tessellated, rhetorical question, and the answer is yes. As a distributor of any health and wellness product, you and only you are responsible. Not only you, maybe you and some other people, but who cares because they’re not you. We’re talking about you, and you care about you. You are legally and pocket-wise, responsible for the consequences.

We mentioned in another video, a client came to us recently that had made claims, and they received not a warning letter from the FDA, but a demand letter from a class action plaintiff’s law firm for the unlawful claims that the law firm said they’d made for their dietary supplement, their medical device, the cosmetic, whatever it was. They made these claims, they got zero FDA legal review, and now they’ve got a demand letter. So now, they need an attorney to respond to the demand letter, and they’re going to have to pay a settlement.

It’s better to know the lay of the land, and it’s really good to understand this essential division between healthcare services and healthcare products. It’s important to understand that law, like medicine, like healthcare, is nuanced, but there are different branches that … It’s nice to find a medical doctor who knows something about acupuncture or herbal medicine. It’s nice to find a chiropractor who’s not afraid to refer to a surgeon when they have to. It’s nice to find an herbalist that’s also aware of more than the body’s energy system that respects Western medicine. It’s nice to find an integrative medicine clinic, where you can get advice and counsel from the different branches of the healing arts, and surely, it must be nice to find a law firm and/or an attorney where you can find the tessellated monkeys of law assembled together in a jigsaw puzzle that’s going to get you the legal strategies and solutions that are going to move you forward in your health and wellness business.

This is Michael H. Cohen, Cohen Healthcare Law Group. I’m really proud and pleased to present my law firm and our practice to you, and we love working with clients just like you, and we look forward to much more.