In today’s video, we address legal issues and legal risk mitigation for clinical practices that prescribe bioidentical hormones or have a functional medicine or integrative medicine approach.

Hi everyone, 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 scale your healthcare business.

Many of our clients, in fact, are functional medicine docs or integrative medicine doctors and clinics, and I’ve personally benefited from seeing functional medicine doctors and integrative medicine doctors in using these approaches.

Recently we addressed some client questions about legal issues for a physician who wants to prescribe bioidentical hormones within their functional medicine practice.

This physician wanted to serve as a “coach” to patients or clients out-of-state so they could really expand what they were doing.  The first step was to review the states in question and assess whether they even allowed remote prescribing.  Typically states require the physician to be licensed in the state where the patient is located, as well as the state where the physician resides in order to prescribe to that patient.  And, prescribing is the practice of medicine—which means you can’t get away with calling it “coaching.”

Working with nutrition and dietary supplements in general falls in another category: it’s normally not considered a medical “prescription.”  Of course, context matters and that’s where the legal consult is going to have nuances, it’s not simply about black-letter law.

Some physicians do choose to maintain their medical practice and get licensed in many other states. While others decide to let medical practice go and devote their time fully as a “health coach,” recognizing that the legal lines here can be blurry, yet these physicians can help manage their risk by softening the language around the services they offer, and by staying away in general from clinical diagnostic labels and treatment.  We talk about these blurry lines in some other videos.

Of course, it is important to have a robust informed consent. The form has to be tailored to the clinical risks and benefits, as well as the alternatives to the therapy that you’re proposing.

In another note, offering packages raises issues. We talk about some of these on our blog posts dealing with anti-kickback law.  Yet here too we want to distinguish the strict letter of the law and risk, from what the healthcare ventures are actually already doing. Feel free to go through the many resources on our website.

Thanks for watching. Please feel free to contact us with your questions. We have helped hundreds and hundreds of healthcare industry clients just like you build their dream.  We look forward to working with you to help grow your success!