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Medical Spas' Benefits Come With Legal Considerations


 

SAN DIEGO — The demand for medical spa services is holding steady despite the current economic downturn, Michael R. Lowe, P.A., said at the annual conference of the Medical Group Management Association.

"I represent about 25 medical spas, and I haven't seen any of them slow down in the last 6–8 months," said Mr. Lowe, a health law attorney based in Longwood, Fla. "Most of them are diverse in what they do, from laser hair removal to hormone replacement therapy, but the baby boomer generation is driving this. They're smart consumers, health conscious, and they want to see a doctor on their terms."

Add declining physician reimbursement from third-party payers and increasing costs of running a medical practice and you have a lot of physicians considering adding medical spa services to their practice. Such services may include Botox injections, dermal fillers, mesotherapy, intense pulsed light treatments, massage therapy, hormone replacement therapy, laser hair removal, weight management, or diet and nutritional counseling.

Mr. Lowe outlined the following points to consider before adding a medical spa service to your practice:

Know what licenses are required. Laws vary by state, so check with your state medical board or an experienced health law attorney. In Florida, for example, a medical assistant can assist a physician with a Botox injection, but only under the personal supervision and involvement of the physician.

"Doctors get that confused," he said.

He also noted that Florida mandates that only licensed nutritionists can give nutritional advice. Mr. Lowe noted that he has represented personal fitness trainers who have been investigated for imparting nutritional advice to their clients. "I've had to defend them against the state medical board and the department of health for the unlicensed practice of medicine, which in our state is a third-degree felony," he said. "So be very careful."

Find out your supervision requirements. Laws on this vary from state to state, and can be murky. For example, in their meeting minutes the Florida Board of Medicine states that to provide laser hair removal you must be a medical doctor, a doctor of osteopathy, a nurse practitioner, or a physician assistant.

At the same time, a state statute mandates that laser hair removal be directly supervised if it's performed by a nurse practitioner or a physician assistant. So if a complaint involving laser hair removal comes before the Florida Board of Medicine, Mr. Lowe said, it is more likely to apply its policy from the meeting minutes than from the state statute. "The best thing you can do is call your licensing board or hire a lawyer who has experience in medical spas and these types of issues," he said.

As a starting point, "make a list of everyone working for you and what service they provide."

Determine if the service is covered by your liability insurance. Check with your carrier to make sure you're covered. "In Florida, a lot of medical spa services aren't covered and the carriers are very resistant to cover them," he pointed out. "The last thing you want is to have an untoward outcome and have a patient come after you and not be covered. The most expensive thing about malpractice is paying the lawyers to defend you."

Be careful with medical director agreements. What duties will the physician perform as medical director? These should be specified in the agreement. Mr. Lowe recommends having the physicians track their hours and the performance of their specific duties.

In order to be compliant with federal law, the medical director agreement must be in writing and signed by all parties involved. It must cover all of the services to be provided by the physician. Understanding the Stark federal antikickback law and regulatory safe harbors legislation is also essential.

Obtain informed consent for all procedures. Mr. Lowe advises having Medicare patients fill out an Advance Beneficiary Notice. "That way they can't come back to you and say, 'You didn't tell me this procedure wasn't covered. … You didn't tell me what I was getting. You didn't tell me how much it would cost.'"

Communicate off-label medication uses. Be sure to inform the patient and discuss all potential risks while having the patient sign an informed consent. Note the discussion in the medical record as well.

Be mindful of patient privacy rights. If you breach the Health Insurance Portability and Accountability Act and cause the patient to suffer, "you may be liable," Mr. Lowe said. "Be careful with this, especially if you work with nonlicensed health care professionals [who don't understand the law]. People are looking to sue for privacy issues."

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