Do Functional Medicine, Anti-aging, IV Infusion Raise Legal Concerns?

Do Functional Medicine, Anti-aging, IV Infusion Raise Legal Concerns?

In today’s video, we return to legal issues in functional medicine and anti-aging practices, including IV therapies.

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

These days a lot of people are interested in boosting their immunity, and IV infusions like vitamins, glutathione, NAD, various cocktails, they are popular.  Sally, a licensed MD, wants to set up her IV infusion practice within a chiropractor’s office.

Why? The chiropractor has great marketing and space, and they can cross-market together. So, what are some of the legal risks and how can she mitigate these risks?

A lot depends on State law. Let’s just focus on the infusion cocktail itself. In some States, you can research the statutes and regulations for “infusion” and you will find nothing.  So that means you have to understand the whole regulatory scheme and issue-spot where the danger zones are.

The first will be who can do what under their license.  For example, let’s say the physician wants to do the therapy or delegate the therapy yet retain supervision, who can perform the IV infusion: a registered nurse? A medical assistant? How about the chiropractor?

Sometimes laws and regulations will address things like laser treatment, hair removal, Botox®, collagen, and other injections.  Many times, these can only be performed by physicians, physician assistants and nurse practitioners or some other limited mid-levels, but not registered nurses, or cosmetologists, or estheticians.  The law might define “supervision” or might leave it undefined, or it might distinguish “direct” from “indirect” supervision.

So, for example, In Florida, there is a rule that requires that the place of supervision be within 25 miles of the primary place of the physician’s main practice in a county that is contiguous, but no further than 75 miles. So that’s pretty specific!

The rules might talk about standing orders, protocols, or standardized procedures; So you need to review State law to see exactly what is required.

Because these rules are so specialized, it pays to have a healthcare lawyer who can spot the issues and understands how the entire regulatory scheme fits together. And we’ve just tapped into a handful of these.

If you’re interested in an early read on your healthcare business model, normally you would probably benefit from having a Legal Strategy Session with a member of our Legal Team.

Thanks for watching. If you still 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 venture, we look forward to speaking with you soon.

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