By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

When patients at medical spas agree to undergo treatments, they are putting their wellbeing into the hands of the physicians who treat them. Because of this, the physicians have a duty to be as transparent and forthcoming about the treatments they provide as possible. They need to tell their patients everything the patients need to know about the procedures they recommend, and they need to make sure that the patients completely understand what is being discussed. This is known as informed consent, and it is extremely important for medical spa owners and operators to understand what is expected of them in order to remain compliant with any laws to which they are subject.

What It Is

Informed consent is a necessary step that a physician needs to take, but it is also a somewhat nebulous concept, from a legal standpoint.

"There's nothing required to put something in writing, as far as a disclosure," said Jay Reyero, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. "I think the whole point of informed consent is to demonstrate that the physician or the provider has given the patient all the material information they need to make an informed decision."

This can often be accomplished verbally, though the patient will need a sign a form stating that the physician has given him or her the information needed to make a sensible decision. However, putting everything in writing is an extra step that, while not necessary, can save a practice some headaches in the future.

"Nothing prevents anyone from putting more information down on paper and being very clear, and I would say that that's the best-case scenario, because it's very hard to argue against the fact that someone did disclose something to you if it's sitting there on a page that you initialed next to or you signed," Reyero said.

Regardless of how the physician chooses to obtain informed consent, however, making sure the patient actually understands the ins and outs of the procedure is the primary objective.

"The whole point of informed consent is that there's certain information that a patient needs to be able to make an informed decision as to whether to go through with the procedure or not," Reyero said. "When we're talking about informed consent, we're not just talking about a consent document—it's more about all the information surrounding what goes into that particular document that they're signing."

The physician should convey information about the nature of the procedure, the potential risks and outcomes, and what to expect in the days and weeks following the treatment.

Going Off Label

One might presume that informed consent takes on even greater importance when a physician utilizes pharmaceuticals or devices in ways that are not explicitly approved by the U.S. Food and Drug Administration (FDA), also known as off-label use. After all, it stands to reason that a patient would need to know that the drugs being used are not indicated for this particular treatment. However, Reyero says that this actually makes very little difference in the informed consent process.

"Generally speaking, there's no requirement to disclose that something is being done off-label, primarily because that's being decided in the professional medical judgment of the physician, and so there's nothing that specifically requires a physician to say, 'This is off-label use,'" he said.

However, a meticulous practice may want to include this information when providing informed consent to patients. This level of transparency will never hurt a practice from a legal standpoint, even though certain patients may be more skittish about such things than others.

"There's nothing that would prohibit someone from taking an added step of saying, yes, we want to create more protection for ourselves, so we're going to go ahead and disclose that this is off-label use," Reyero said. "But when you think about what off-label use is, that in and of itself doesn't necessarily convey anything that's material to what a patient would want to know to decide whether they should go through with the procedure."

After all, the fact that the FDA has not approved a particular drug or device for a particular treatment should not necessarily matter, since FDA approval should not be taken to mean that any sort of non-indicated use is dangerous. In fact, board-certified physicians engage in off-label use on a daily basis, and if they are doing it in a conscientious manner, it is perfectly legal for them to do so.

"Off-label use just means that the FDA hasn't approved this particular drug or this particular device for the particular use that we're going through," Reyero said. "It doesn't pass upon whether that's safe or not, and so that's why there's no specific requirement or duty for a physician to disclose that."

Trials and Tribulations

On the other hand, if a physician is conducting clinical research and wishes to use a patient as a participant, the informed consent process is vital and must be handled with the utmost care.

"The FDA actually has a fairly comprehensive set of requirements for informed consent with respect to clinical trials or research," Reyero said. "It's a much, much more comprehensive discussion. The FDA terms informed consent as being a process. It's not just saying, 'Will you participate in this research study?' It's talking about what that research study is, and what to expect, and what not to expect, and the things that they could experience, and allowing the person plenty of time to consider the information and to speak with someone. It is much, much, much more comprehensive than your standard medical procedures."

These guidelines can be found on the FDA's website. The U.S. Department of Health and Human Services' Office of Human Research Protections also offers a set of tips about obtaining informed consent for doctors conducting clinical research; these can be found here.

"It's so much more comprehensive than just your standard medical procedure with its informed consent," Reyero said. "Typically, that is judged based on the disclosure of material information that a reasonable person would want to know, or disclosure of material information that a reasonable physician would think is important for a patient to know."

Location Location Location

As is often the case with the regulations that govern medical spas, informed consent requirements vary from state to state.

"Every state is different," Reyero said. "They're all going to have different informed consent statutes or informed consent laws. If someone feels that a doctor didn't disclose something or did something wrong, they're either going to sue them under a non-disclosure-type concept where they didn't properly give informed consent because the physician didn't disclose enough information, and that's where those reasonable standards come in."

More often, though, patients invoke their states' negligence statutes, as they typically feel that the physician's medical judgment did not live up to the standard of care the patient expected. These vary from state to state, so if a medical spa suspects that its physician is not doing enough to obtain informed consent, it needs to review its state's laws and its current procedures with an experienced healthcare attorney to determine what additional steps need to be taken.

Evolution

Today's medical spa patients are more concerned than ever before about knowing precisely what is going on with their treatments, so practices and physicians should expect that informed consent regulations will probably evolve to become stricter in the future.

"People out there feel that there should be more information given to patients to make these decisions," Reyero said. "With healthcare, everything is about patients understanding and everything being transparent, and so there may be something of a push for more disclosures than not."

Reyero recommends that physicians reveal everything they can to a patient up front, because whether or not they are required to do so, it offers patients peace of mind and offers physicians security from a legal perspective.

"My rule of thumb is always disclose as much as possible, because it can only protect you," he said. "In reality, when you think about going to a doctor's office or going to a provider's office, just because something is two pages as opposed to one doesn't affect my judgment. 'I'm going to leave because now you're having me sign four pages instead of two,' or 'I can't believe they [require you to] sign so many pages; I'm not going to recommend them to my friends'—those aren't really criteria for people who are selecting healthcare providers. I always say that if you can put more in there and show that you've talked with them and disclosed things and given them time to ask questions, you're only going to better protect yourself in any claim that they did not fully understand what was going on."

Ultimately, it is a physician's duty to make sure his or her patients know what they are consenting to. They should be as transparent as possible and be thorough in documenting the fact that they have had those conversations. It will put them in a much better position if there's some sort of legal entanglement as a result of a bad outcome.