In today’s scenario, a psychiatrist desires to prescribe ketamine to psychiatric patients for mental health, via telemedicine.  The psychiatrist wishes to prescribe across states yet is only licensed in California.  What legal risks present, and how should a healthcare attorney guide this kind of a physician client?

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.

This scenario has a number of nuances.  First, you have a psychiatrist, a licensee.  Telemedicine rules typically require that the physician abide both by the law of the state in which they reside, known as the Home State, and the state in which the patient resides, known as the Remote State.

Second, whenever a physician wants to use a therapy that is edgy or controversial, a key concern will be how much the therapy would be considered by peers to be supported by evidence (to be evidence-based), and whether the therapy is such an outlier that the State medical board might raise disciplinary concerns.  Standard of care will figure into the equation.

A third issue is whether a good faith, in-person, appropriate prior examination is necessary to prescribe.  Some states require the appropriate prior examination, some do not.

One option would be to have a mid-level such as a Nurse Practitioner serve as “boots on the ground” and do the initial patient consult, assuming the NP is indeed licensed in the Remote State.

This then triggers the issue as to whether the physician, who is only licensed in the Home State, can be considered to be adequately supervising the NP, under relevant legal rules.

In our scenario, the physician’s marketing plans themselves also would raise regulatory concerns.  Here the marketing plan is fairly aggressive, with direct marketing, social media marketing, dinners with patients and referrals.

The fact that the IV ketamine is offered on a cash basis—without submitting claims to insurance—invokes a separate legal thread but does not alleviate some of the legal concerns we’ve already mentioned above. So cash-only doesn’t solve all the problems.

Next, the physician plans to provide “packages” for treatments.  The packages raise issues as to whether they contain inducements to consume medical services, also known as kickbacks.

Complicating the picture yet further, the physician wants to integrate these packages, into a health coaching program with counselors and coaches who will be educating the patients as to the benefits, and risks, providing educational support, and likely, they’ll also be marketing and selling the programs.

We haven’t even talked about the referral fees the physician wants to build in.

As you might glean, this is not your cookie-cutter physician practice.  No, there are so many bells and whistles here, it’s going to take work to unpack.  But this is a typical presentation.

As healthcare lawyers we look at these kinds of scenarios through a risk-based analysis. We’re not looking for Yes/No. Some activities are riskier than others.  For example, with physicians, referral fees almost always raise kickback red flags.  Then you have the therapies that are not standard.  And then you have the issues involving the good faith exam, the use of mid-levels supervision and so on.

And then, of course, the prescribing of a controlled substance and across state lines.

Telemedicine meets coaching meets scope of practice meets fee-splitting.  Something like that.  Rest assured our approach is to unpack, spot the issues, tease out the threads, one by one, so we can do a proper analysis.

Sometimes clients don’t understand this, they approach us with this level of complication and even before they even have engaged our services, they demand a yes/no as to whether their particular envelope-pushing idea is feasible.  Obviously, the doctor can’t order the surgery until after they have examined the patient, done lab tests, made a proper diagnosis and created a treatment plan.

So, this is what we do.  Every week we tackle dozens of complicated healthcare ventures.  Over 400 clients a year at this recording trust us to give them critical legal advice for their healthcare business.   And we’d like to welcome you to our legal family.

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.