Regenerative Medicine & Stem Cell Practice in Medical Spas – Legal Alert
In today’s video, we talk about how medical spas and medical practices handle some of the legal issues with regenerative medicine, and stem cell therapies.
I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised hundreds of healthcare industry clients on healthcare and FDA legal issues. Our clients include medical spas and healthcare companies that work with stem cell therapies and regenerative medicine.
We’ve also gotten a lot of client questions about use of stem cell therapies, whether by medical doctors, naturopathic physicians, or midlevel practitioners such as RNs. As healthcare and FDA attorneys working in regulatory territory, we receive many deep-in-the-weeds questions.
For example, what about injecting stem cells for beauty and cosmetic treatments?
Using stem cells in IV infusions?
Are stem cell therapies covered within state law on nonsurgical medical cosmetic procedures?
Do stem cell therapies require an initial, in-person exam by an MD or under MD supervision by a PA or in collaboration by an NP?
What about procedures such as micro-needling, do these require medical supervision and a good faith exam?
Let me give you three tips to help you keep you in mind when you’re looking to get a healthcare lawyer to address these kinds of legal questions.
First, a lot of the law simply says “no.” It doesn’t tell you what you can do, only in broad terms what you can’t do. So, when you’re looking for legal advice, you’re really asking for a professional read by an attorney, between the “yes” and the “no.” Obviously, either extreme is unsatisfying and doesn’t give you any real guidance.
What you want in a healthcare lawyer is knowledge, skill and experience. A good healthcare lawyer can tell you, this particular scenario is more likely to get you in regulatory trouble, that scenario is more likely not going to be the biggest enforcement priority.
This week, one of our clients, a medical doctor who also runs a medical spa, told me that his biggest competitors were marketing and advertising their services, using advertising copy that he considered deceptive and misleading. He was at wits end trying to compete with these industry players who just don’t follow the rules. It’s not fair.
We talked through some of the strategies they were using and the legal risks that they were undertaking. Finally, he listened, and concluded: “don’t poke the bear.” In a way, the process of mapping out the regulatory landscape helped him clarify his own business decision.
Second, a lot of these questions come under state law and they have to do with what licensing statutes, regulations, and Board policy statements say.
The federal government doesn’t regulate the practice of medicine, or the healthcare practice of other licensed professionals. Rather, the United States Constitution leaves the regulation of health, safety and welfare up to the States.
And so, each State will have different laws and rules about what medical spas can do; about who can do what kinds of therapies; about whether you need a doctor to perform therapy X or Y or whether this can be done by an RN under MD’s supervision; or, whether some services can and can’t be performed by a licensed esthetician, because for example, they might constitute the practice of medicine.
Depending on your legal budget, it often doesn’t make sense to research the law in all states, or even a lot of states. If you’re a medical spa in one location, then obviously, your state law matters; and if your business is multi-state, sometimes we focus on key states or we get a small sampling of the ones with the toughest rules.
My third tip is, don’t rely on advice which you got from someone else, because it is often incorrect, and based on facts and circumstances that don’t necessarily apply to your situation.
As an example, recently, one medical spa came to our Firm with all of these questions swirling around in their minds. They were worried, because a medical spa in the same neighborhood had been visited by a very, very, super friendly medical board investigator, who was asking too many questions, in too friendly a way; and across town, medical spas had been raided by enforcement officials in a very heavy-handed way.
Up till then, the medical spa had thought it was “legally safe,” because, after all, it had a “HIPAA-compliant” software platform, and had its doctor making remote Skype calls with patients, before the RN would initiate a whole host of regenerative medicine therapies.
This kind of scenario in fact created much regulatory jeopardy.
The medical spa client basically told us: “we use stem cells we get here from Company X, we mix them up in the back of our office with formula Y, then we inject them here and there as the doctor emails us, we’re only doing it for beauty, we think it’s ok, we just want some clarification on the laws.”
OK, so if the speed limit is 55 and I’m going 90, but I’m telling you it’s ok because I’m driving an old Chevy, my seat belt if fastened, I have a radar detector, and I’ve also surrounded myself with white light and asked the angels to protect me – which by the way is not a bad idea, but don’t rely on it when you go 90 because if I drive too fast and I have a long way to go and I want to get there quickly … all I want to know is, i just want to know if am I legally ok … I mean, my cousin’s lawyer’s half-sister’s friend, who swears by this and also asked a lawyer, said it was ok, as long as I don’t go over 90 miles an hour ….
I know it sounds really silly, but it’s the sort of thing we hear, in one form or another all the time.
And that’s why you can’t take excuses, and your healthcare lawyer’s experience and professional lens can help you interpret the law.
Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
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.