In today’s video, we talk about laws governing mobile patient services such as IV hydration, vitamins, and concierge medical spa services like Botox.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so you can launch, or continue to scale, your health and wellness business.

Our hypothetical client is a physician assistant who would like to provide mobile patient services like IV hydration, IV vitamins, and concierge medical spa services like Botox.  The PA proposes setting up a PA corporation but wants to know whether she should instead become a 49% shareholder in a professional medical corporation, where the physician controls 51%.  She also asks about physician supervision; liability risk; consent forms; telehealth; questions about office policies; confidentiality, privacy and security; and general liability questions.

Let’s start with some basic legal definitions from the California Business & Professions Code that can apply to this kind of business and to registered nurses and physician assistants.  Just to show you some of the complexity, not even getting to the issues of control over the business: there are three different words that sound like they might have similar meaning: “administer,” “furnish” and “dispense.”

First let’s take the word “administer.” “Administer” means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion, or other means. This is from California Business & Professions Code, Section 4016.

Then you have “furnish.”  “Furnish” means “to supply by any means, by sale or otherwise.”

And then there’s this word: “dispense.”  To “dispense” is normally, “furnishing drugs or devices upon a prescription,” typically from a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor; sometimes on an order from a certified nurse-midwife, nurse practitioner, physician assistant, naturopathic doctor; also includes furnishing directly to a patient.

Then you’ve got the term “dangerous drug,” which means “any drug … unsafe for self-use in humans …” typically means Rx or prescription drugs.  And within dangerous drugs, you got controlled substances.

You have to put this whole combination of legal definitions together, and some other statutory restrictions, to figure out who actually can issue the “prescription,” to whom because let’s say it’s your PA client—or maybe your registered nurse—they might be able to administer or furnish, but they have to get the actual prescription from the physician.  That is because Section 4040 defines “prescription” in terms of the physician and other designated licensees.

Only once you get through who can prescribe and who can administer, furnish, or dispense, then you got to issues about the good faith exam—which have recently been loosened, and which we discuss in companion videos, on telemedicine; you got to meet standard of care; there’s informed consent.

Get through all this, you get to the question of IV services, and then, whether you can provide them through mobile outpatient care, and finally, care at the patient’s home.

Now, there might also be questions about the IV solution itself and its FDA status, especially if your business model involve compounding drugs, and, if the healthcare practitioners are to be adding to the solutions on-site.  This might be tantamount to manufacturing and distributing an unapproved new drug.

There are also legal rules governing storage of these products, and there’s questions about the physician’s role in supervision and documentation.

So, what we’ve done very quickly is to give you a little taste of legal issue-spotting.  This isn’t a comprehensive, encyclopedic review of all the laws related to your IV hydration mobile business, it’s a glimpse.  And with a glimpse you get an early sense of the layers of legal analysis and the depth of legal waters or regulatory waters your business will have to navigate.

Now, if you’d like an early read on your business model, we typically give you a low barrier to entry starting from a Legal Strategy Session. So, feel free to ask our team about that.

If you have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare business, your venture, and we look forward to working with you soon.