By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)
Medical spa owners and operators typically don’t think their businesses are going to be investigated by the regulatory agencies in their state, and historically, this is often the case. Agencies simply can’t keep an eye on every practice under their jurisdiction, after all. However, the recent growth of the medical esthetics industry has increased the amount of scrutiny it receives from these agencies, so the odds that your medical spa is going to be investigated are improving all the time.
If you practice is investigated, the consequences can be severe. Depending on what the agency finds, the practice’s physician’s license could be suspended, which could cause the practice to be unable to operate, and heavy fines may be levied. Severe infractions can even result in criminal prosecution. Understanding why these investigations are triggered will help you avoid them, so here are the top reasons why medical spas are investigated.
Most of the procedures performed at medical spas are considered to be medical in nature by regulatory authorities. Before these treatments are administered, a physician generally must conduct a face-to-face examination, wherein he or she determines the patient’s overall health and the extent of the patient’s issue. After this exam, the physician suggests a course of treatment. However, regulatory agencies have disciplined many medical esthetics practices because they do not properly administer these exams; in fact, this is the most common reason why these investigations are initiated.
Uncertainty over the status of minimally invasive treatments, such as Botox and filler injections, tends to lead to these violations. Many seasoned nurses have been cited for administering these treatments without an exam because they think an exam is not required, since for many of them, that’s the way it has always been.
In most states, the initial exam can be delegated to certain licensed practitioners, such as a nurse practitioner or a physician assistant, but the physician still must be involved with establishing this protocol and make sure it is always followed. Medical spa employees must understand that doctors are entirely in charge of medical treatments at their practices—only they can set the protocols, only they can set the treatment plan, and only they can prescribe and delegate others to perform that treatment plan.
Along the same lines, because medical spas are medical practices, a medical professional must always be on site. While a physician can delegate most of the practice’s medical treatments to others, including non-licensed individuals, a licensed professional—a physician, nurse practitioner, physician assistant or registered nurse—should be at the practice at all times to oversee these procedures. The type of treatment provided, as well as the type of practitioner performing the treatment, are important considerations, so if you’re not sure how your state defines certain treatments, check with your local health care attorney for more information.
Some procedures, such as microneedling and dermaplaning, traditionally have not been viewed as medical treatments, but now typically are. This complicates matters at medical esthetics practices where estheticians have been performing these procedures for years. Additionally, most states require a tattooing or permanent makeup license to administer microblading, which complicates matters further.
At some medical spas, physicians don’t pay much attention to what is going on and essentially serve as medical directors in name only. Some physicians oversee more than a dozen medical spas, which should tell you that they spend very little, if any time actually working at these practices. These practices probably do not have proper oversight, unless they have a large number of nurse practitioners or physician assistants on their payroll. Regulators can easily see if a physician appears to have too much going on and use that as a reason to investigate what’s happening at his or her medical spas.
Regulatory agents tend to spend a lot of time searching the internet for potential violations, due to the lack of funding their agencies receive. If they search for terms such as “medical aesthetician,” for example, it’s not terribly difficult for them to find violations. Additionally, they typically can get an idea of the practice’s ownership structure and if it is in contravention of the agency’s regulations. If an agent finds that a practice’s website indicates that, say, an aesthetician or nurse owns the practice—in most states, only a physician or physician-owned corporation can own a medical practice—he or she likely will not hesitate to open an investigation of it.
Additionally, Medical spa owners and operators should not present testimonials that are hyperbolic or suggest that the practice offers services it cannot actually provide. Medical advertising regulations dictate that practices must only cite skills and accomplishments that can be proven. For example, if your practice advertises “the best Botox in Boston,” it is likely to draw attention from regulators, since that is not a fact that can be verified.
Regulators also search for indications that a practice has violated patient privacy laws, such as HIPAA, on social media. Anything that can identify someone as your patient—down to simply responding to a patient’s Facebook post—can be interpreted as a violation, provided you have not obtained the patient’s consent in advance. If you’re not sure if your social media activity is violating patient privacy laws, consult with an experienced health care attorney as soon as possible. (Author’s note: AmSpa works with national law firm ByrdAdatto, which focuses on medical aesthetic legalities, and as a member, you receive a discount off of your initial consultation, along with a number of other great benefits. To learn more about the benefits of an AmSpa membership, click here.)
Drugs & Equipment
Regulators are likely to initiate an investigation if a practice is found to have purchased pharmaceuticals that claim to be cleared by the FDA—but are not—from overseas sources. Only drugs and equipment that have been totally approved can be purchased legally in the United States; importantly, this means that in addition to the actual product, the FDA has approved all packaging and inserts.
There are two aspects of this issue. On one hand are potentially dangerous counterfeit drugs—typically Botox and fillers—that typically are manufactured in and purchased from China; these should be avoided at all costs. The prevalence of these products has declined in recent years as more owners and operators have learned about how dangerous they are, but they’re still out there.
On the other hand, “parallel importation” is a practice in which legitimate products sold in countries where price controls keep the cost of prescription pharmaceuticals low are resold to practices in the U.S. for far less than they would cost if purchased domestically. Parallel importation is broadly legal for most products, but it is understood to be illegal with pharmaceuticals, and the FDA has indicated a willingness to prosecute the practice. If your medical spa is found to be engaging in parallel importation, it very well might trigger an investigation.
Filing with the State Board of Cosmetology
Medical spas have to spend a lot of time and effort complying with regulations involving the administration of medical treatments, but they also must follow the rules related to purely aesthetic offerings. Most state boards of cosmetology require businesses that provide such services to apply for a cosmetology “establishment license”; this is called different things by different states, but essentially it is a registration with the board of cosmetology declaring that aesthetic services such as facials are being performed. Medical spas understandably tend to be much more concerned with maintaining medical compliance, so they often neglect to obtain this license.
Boards of cosmetology seem to be less formidable adversaries than medical boards, but they will cause significant problems for medical spas that ignore them. If your practice offers esthetic services, make sure it is in full compliance with the state board of cosmetology.
Straight & Narrow
Ninety-nine times out of 100, an investigation into a medical spa is triggered by a report to a regulatory body, and this is more likely to happen as a practice become more successful. Competitors might report a medical spa, sometimes for good reasons and sometimes out of professional jealousy.
Also, patients who are disappointed with the way they’ve been treated—whether they’ve actually been mistreated or not—may report a practice to a regulatory agency. A patient is unlikely to grumble if they he or she has a good experience, regardless of the outcome, but medical spas should always strive to provide patients with exceptional service so that they don’t do something irrational—after all, as all medical esthetics practitioners know, medical spa patients are, let’s say… a passionate bunch.
Finally, it’s not unusual for former employees to report medical spas to regulators if their departures were not amicable. Upon hiring new employees, a medical spa should set realistic expectations, provide proper job descriptions, and make sure they understand procedures, so that if they are terminated, it won’t be seen as a surprise or viewed as unfair in any way.