This is Michael H. Cohen, President and Founding Attorney of Cohen Healthcare Law and I’m here to get you excited about your healthcare project, your health and wellness company, your healthcare service, whether it’s a clinic, a clinical laboratory, a medical group, a practice, a naturopathic medical practice, a joint venture between a chiropractor and an MD let’s say focusing on stem cells, or maybe it’s a healthcare venture. Maybe you’re doing a home infusion IV hydration therapy business.
That’s about eight nouns in a row, but who cares? You get the idea. Right?
It spells delivery of healthcare services, use of the internet, healthcare as a product, telemedicine, and questions of the good faith exam.
Do the same rules apply to you as a medical spa?
What kind of consents do you need?
Who does the patient belong to?
Who owns the records?
What are the arrangements between the MSO, the Management Services Organization, and the physicians?
Can an RN do certain things?
Can the RNs carry and transport and store the IV bags? Are the IV bags drugs?
Are they regulated as dangerous drugs?
Who can control them?
What are the rules?
You get it. It’s a morass. It’s a Labyrinth. It’s a maze. It’s a regulatory maze. What makes us different? People come to us for legal strategies and solutions. We provide legal strategies and solutions to businesses and practices that accelerate health and wellness. And I’m excited about it.
This morning I’ve been listening to motivational talks and I’ve had my own healthcare transformation revolution. A revolution of the mind, if the mind is clear when the doors of perception are cleansed, then perception is infinite. Aldous Huxley. Read a wonderful book about that. Probably had to do with Aldous Huxley’s experimentation with illegal controlled substances.
Anyway, that was before all these laws came into place. And I was in college, so I wasn’t a healthcare lawyer. I didn’t experiment. I didn’t inhale, I didn’t ingest. I’m watching this Sci-Fi drama Osmosis about this capsule that has an app inside it. It releases nanobots inside the brain and people are supposed to find their perfect love. But maybe they don’t because this little thing called the Human Condition intervenes. This little thing called the Regulatory Structure intervenes. Between the truth and the objective falls the shadow, to paraphrase T.S. Eliot.
I’ve been listening to this motivational stuff. I’m going to try being a little bit more motivational because one of the issues that most of you face with your healthcare or FDA lawyer who you currently have on retainer or whom you fired in the past or maybe the past four, five or six lawyers that you’ve retained, is that frankly they sound like Eeyore. Eeyore is very depressed and everything he has to say is very glum.
Or maybe they sound like the character in Rocky and Bullwinkle. “We’re doomed. We’re doomed.” It’s the anti-kickback statute. It’s HIPAA. It’s malpractice liability. It’s risk from every single angle. It’s medical board discipline. It’s all going to end. “Chicken Little, Chicken Little the sky is falling down.” That’s what your lawyer said to you. We’re not like that.
What you would love is for me to say, “Listen, You would love for us to say that we would be the lawyers who would green light your proposal, give you the official certification, the guarantee, the seal of approval. And once you have that from us for a low, low, low price now you’re going to go out and market your healthcare service or product free. You will have your get out of jail free card”.
You will not be worried about stark, anti-kickback, fee splitting, patient exploitation, fraud and abuse, HIPAA, state privacy and state security laws, data breaches, liability therefrom, liability flowing from who knows what, liabilities that are not provided for in your contracts, malpractice, negligence, negligent credentialing, inadequate consent forms, corporate practice of medicine, corporate practice of psychology, corporate practice of who knows what, unlicensed practice of medicine, psychology, social work, nutrition and dietetics, or something else.
While federal Stark and anti-kickback laws, and state law equivalents (often known as “mini-Stark” and “fee-splitting prohibitions”) are very complex, there 5 key legal rules you’ll want to know. […]
The Stark Law is named after California U.S. Congressman, Peter Stark. It seeks to regulate how physicians refer Medicare and Medicaid patients. The law is part of the Omnibus Budget […]
Fundamentally, you’re worried about legal rules prohibiting kickbacks, fee-splitting, corporate practice of medicine, as well as Stark law; you don’t know whether the MSO or management structure […]
Who knows what the next frontier will be of regulatory liability. You could be slapped with a lawsuit from a private plaintiff. Maybe some enterprising class action lawyer finds out that no, you said you were selling mushroom burgers and on 1% of the burgers out there your employee forgot to put mushrooms on them. That severely damaged customers, so that’s a multi-million dollar claim.
Or your website is not in conformance with the disabilities requirements now for websites, those standards. Or you didn’t comply with, say in California, Business and Professions Code 17600, which has to do with automatic disclosures. We’ve had clients who’ve been hit with assaults from class action plaintiffs on various fronts. Whether or not they relate to the healthcare core of regulatory issues, the private plaintiffs will seize on something and juice it up into a claim of unfair business competition, or some statutory violation that may or may not even be related to the underlying healthcare regulatory issues.
California, like other states, makes online tracking of personal information disclosures required in website privacy policies.
Wouldn’t it be wonderful if we could just be 100% enthusiastic? And we are enthusiastic. I’m very charged today. I’m very pumped. And I realize that you have to have this can-do mindset because that’s what our healthcare and FDA clients like is they like someone who joins with them in their effort and in their passion to transform healthcare. Not only to transform healthcare, but to challenge existing paradigms and to evangelize their models of digital health.
Whether they’re an integrative medicine, functional medicine, the hydration therapy and/or IV therapy model that I discussed earlier that I touched on early, medical spas, telemedicine, use of artificial intelligence and algorithms, and genetics, genomics, nutritional genomics. The list goes on and on. Whatever the new therapeutic approach is to health and wellness and the packaging of the delivery of health care as part service, but part product with software, the computer, the internet, the digital world mediating. Clients would love us to give them the great stamp of approval.
We don’t do that. We have disclaimers. We’re caveats. We’re lawyers. I am wearing dark, even though it’s not a dark suit and I’m not wearing a tie, but we are not Eeyore. We are not ashen-faced. We are neither demons nor angels. With the word evangelist contains within it the word angel. But we’re here to support you on your health and wellness journey. We’re here to walk you through the nitty-gritty legal issues. Often we do it through a legal strategy memo, which lays out the regulatory landscape and sets out the blueprint, your legal foundation.
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 […]
Just the other day I talked to a company. They have three to five million dollars in revenue. Probably somewhere between. Probably four, but it’s climbing. Heavy upward projections. They’ve been through many, many lawyers. The lawyers gave… Most of them said no. Some of them gave a very canned response. I asked them, “Was the advice largely verbal or was it in writing? Do you have anything in writing that creates a legal roadmap for your business?” And they said no.
They told us,
We have to have a professional corporation, but then we do this in the MSO. Then everything gets loaded up into the MSO so that all the value’s there. And yet, we’re doctors so we’re not sure how we use the Professional Medical Corporation that we want to expand into different states. And then there’s this other wrinkle. We want to hire mid-levels to do these therapies plus we’re training doctors. So we’re doing some things that maybe seem clinical, but maybe seem like they could be done by a management company. We’ve gotten different advice. The arrows point in every direction.
And frankly our current big firm lawyers who are statewide experts in healthcare in the state of X, they are conservative. They are boring. They don’t give us news we can use. Could you please help us present your multilayered solution or suggestion and recommendations so that we can get our business model four years later and millions of dollars in revenue later finally on a firm foundation so that we keep our licenses as doctors. Not to mention don’t go to jail for a kickback violations, don’t handle fee splitting, don’t have corporate practicing medicine issues.
Growing Pains in Your Healthcare Practice or Healthcare Venture? We’ve had many clinical practices and healthcare ventures come to us asking how to mitigate risk of anti-kickback and […]
What’s the retainer? It’s the usual. It’s small, medium, or large. But it’s something really manageable. I mean, if the retainer was 25 thousand dollars and for 25 thousand dollars you could solve a 4 million dollar year problem and being mature, more mature in your business and having conflicting arrows with no solid written initial foundation, wouldn’t it be worth it? What if you could get that for half or even a third of that cost or maybe even a quarter or maybe even a fifth? Wouldn’t that be amazing?
Get excited. We’re with you. We’re passionate. Make no bones about it. I’m in health and wellness because I believe in it, because I’m passionate about health, because I like to look and feel great. And I also believe in the spiritual dimensions of health. If you read my academic legal scholarly writing, you’ll see. Those seeds are implanted throughout that work. And I believe in you. We are angels on your side and we’d love to work with you. This is Michael H. Cohen, Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses and practices that accelerate health and wellness. Call us soon. We’ll look forward to working with you.