You’ve started your own integrative medicine and functional medicine practice.  You rented an office or maybe you dove right into a telehealth, telemedicine practice as virtual and digital visits are here to stay.  Let’s say you have malpractice insurance.  You got a logo and even trademarked it.  Now what?

In today’s video, we discuss some legal foundations for your integrative and functional medicine telehealth practice.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. I’ve written a lot of books about the subject and our law firm help healthcare industry clients navigate healthcare and FDA legal issues so they can launch or successfully grow their health and wellness product or service line.

Let’s talk about you.  You might focus on pediatric health, you might focus on geriatric health, or mental and behavioral health, or women’s health, men’s health, addictions, relationships, ADD and ADHD, autism spectrum, or some other aspect of health and wellness. We deal with a lot of them.

You might participate in some insurance, you might be all-cash.  We have separate videos on opting out of Medicare and doing an all-cash practice.  You may offer mind-body therapies: meditation, guided visualization, yoga, relaxation.

You’re also selling dietary supplements, or at least recommending them to patients and providing a portal to a supplement manufacturer.

You’ll have a schedule of services.  For example, a first office visit—again, it might be a virtual telehealth first visit, a digital online health encounter.  Then a follow-up medical check-in at 30 days, or 90 days… depending on the result of the stool test, blood test, urine test, whatever lab test specimen you’ll requisition.

You want to offer a set fee for a suite of services to encompass the lab tests, supplements, the initial and follow-up visit, email, and much more.

So there’s the basic scenario.

What are your key legal concerns, strategies and legal solutions here?

Let’s focus in on three.

First, you’ll want to explore whether packaging these different services together raises a kickback concern, either under federal or state law.  We talk on our blog a lot about kickback issues in concierge medicine.  We’ve been tracking these legal developments for a long time.  Visit our website, cohenhealthcarelaw.com, if you’d like the backstory on stark, anti-kickback and fee-splitting rules – there’s a lot of content.  We also identify risks and some risk management strategies during a live legal strategy session with you.  And, we will want to follow up by drafting a membership agreement between your practice or business and the patient.

Second, you’ll want to have a robust informed consent.  Robust, because you’re practicing integrative medicine, functional medicine, holistic healthcare, wellness care, whatever it is you may be evidence-based but a lot of what you’ll be doing might be considered out of the box by some conventional, in-the-box docs.  So that means you’ll want strong, protective language in your consent form which identifies the approach you’re taking, and the clinical risks, benefits and alternatives.

Then there are a series of forms you’ll want to have in place: for example, your Office Policies, physical or virtual office, so patients know your position regarding refunds, cancellations, mundane housekeeping issues like that—which are best put out clearly so there’s no misunderstanding later.  Then the Privacy Policy and Terms of Use for your website.  Possibly employment agreements for other healthcare practitioners.  And definitely, some vendor agreements, HIPAA-related forms which address privacy and security of PHI or Protected Health Information.

Those are the top line items, but there are many others and you’ll want to at least do a Legal Strategy Session. It’s a great low barrier to get some top-line issue-spotting or recommendations. For example, even if you get everything else right, you can get in trouble with healthcare authorities if you don’t have a good consent form, if you don’t spot the issues, if they say you engage in corporate practice of medicine, if you make an inappropriate disclosure of PHI, like, right at the get go, these things can just tank your business. So we really want to push you in a position early on to map out some foundational legal strategy, and that’s why we start most clients with a legal strategy session.