Each of the 50 states has their own medical practice act that dictates the “who and how” of a medical spa. It can be confusing and hard to consistently comply with these regulations, but it is worth it for a medical spa owner and employee to be ahead of the game and stay abreast of the rules and regulations. The boards that skin care professionals may want to consult with include the boards of medicine, cosmetology, electrology, pharmacy, and even radiology. Often times, professionals post questions on industry social media websites that pertain to a state rule; while this may be a quick way to get a response, professionals should realize that the person responding may not be familiar with their state’s rules and they cannot rely on this source to hold up in court. It is best to contact the state boards and have physical copies of their regulations and handbooks available.
When opening a medical spa, depending on the state, the owner may need to have a medical license. Some states require 100 percent physician ownership; others require at least 51 percent physician ownership; and some allow licensed medical professionals, such as nurse practitioners, physician assistants, and registered nurses to have full ownership. There are also states that allow non-licensed, or lay persons, to own a medical spa.
One study showed that 80 percent of all medical spas owned by non-licensed persons are operating illegally. An example of this may be if a non-professional advertises a medical spa without having a medical director. This violates the corporate practice of medicine law. Some states even require that the advertisement have the medical director’s name listed on the sign, as well as within any social media and print advertisements. The concern with the non-licensed professional owner is that the medical board has no authority over a lay person and, should a client desire to file a complaint, there is no license to review or remove. Therefore, cases like this would need to go to the state’s district attorney for review.
If the clinic is not owned and operated by a physician, the owner needs to find a medical director to supervise. However, one of the first questions to arise when doing so is: how is the medical director going to be paid? Often one hears that the medical director gets a percentage, say 10 percent of profits, but this can be considered fee-splitting. Fee-splitting is also prohibited in many states. An example of this would be if the physician was being paid a percentage of all aesthetic medical fees collected in exchange for being medical director. Prescription services, such as Botox® injections, laser hair removal, or other services performed using a Class II medical device, are all subject to fee-splitting prohibitions. This rule does not apply to facials. The best approach for this situation is to have a set monthly or hourly fee for the physician that matches industry standard and is comparable for the work involved with the medical spa.
Medical supervision is dictated by the states, as well. There are two models of supervision: direct or indirect. In the direct model, the medical director is on-site and performing treatments or sees the patient at the initial treatment, then delegates all follow-up treatments. Using the indirect model, the medical director is off-site or has indirect supervision of the clinic. Some states have more specific rules, such as the medical director must see each patient every three or six months to continue treatments or the they must be within 30 minutes of the practice during working hours. Indirect supervision can be risky for the medical director as they are essentially leasing out their medical license for a fee. The clinic would be allowed to practice medicine under that physician’s license. While not illegal in some states, the lack of direct physician oversight is against the recommendations by the International Medical Spa Association. The risk to both the safety of the client and the physician’s liability increase. To abate this, ensuring that a well-trained and licensed staff is performing treatments according to procedure protocol is imperative. Insurance companies frequently request documentation of the protocols and the level of involvement of the physician with clients and staff.
Deciding who performs procedures is also dictated by the state. Again, medical prescription services – such as Botox®, dermal filler injections, laser, or other services performed using a Class II medical device – are determined according to each state. Some states only allow a physician to fire a laser; other states require laser certifications; and some states do not recognize any laser training. In the states that do not need laser training, it is still recommended that whomever is performing the laser be trained by the vendor of that laser. Most vendors offer complementary training for the staff to reduce the risk of complications and increase positive outcomes. Injectables using needles and syringes typically fall under the license of nurses and physician assistants, as it is within their scope of practice with their medical licenses. Aestheticians and cosmetologists are typically trained to not break the skin or cause bleeding and, therefore, are not allowed to perform injections. Some states, however, allow the medical director to dictate this and if the medical director wants an aesthetician to do an injection, it is legal. Keep in mind, this may not be the best practice for the patient if that aesthetician has not been given extra training in injection techniques, anatomy, pharmacology, and blood-borne pathogens. The main concern should be to keep clients safe and happy. If professionals can do that, their business should be successful.
There are two types of insurances a medical spa should invest in. The first is general liability, which includes coverage for the business and location as a whole. An example of this would be an injury from a client slipping on a wet floor. The second is malpractice insurance, which covers mistakes causing injury made by an employee. While a business may offer a form of malpractice to cover its employees, it is always advisable for each person who has hands on contact with clients to carry their own private insurance. Professionals should remember that just because they have active insurance does not mean they are necessarily in compliance with the state rules and regulations.
It is worth noting that a few states have no rules for medicals spas, meaning they do not require a medical director and may not require a license to practice in the area of aesthetics, massage therapy, or acupuncture. As of February 2018, Arizona and Oklahoma both had bills on the ballot to deregulate the cosmetology industry from allowing nonlicensed professionals to perform services. This may have changed since then. These bills are drafted by politicians that may not have a firm grasp on the reality of the aesthetics industry. This is why it is imperative for professionals to stay up-to-date with their state’s regulations and the industry’s initiatives to change and improve the regulations.
Medical spas are a wonderful environment where clients can get results-driven treatments. Professionals must remember to do their homework and stay current with guidelines and training requirements in order to ensure clients are comfortable and happy so the medical spa business thrives and survives.
Erin Lucie, D.N.P., FNP-C, is a Stillwater, Oklahoma native, where she obtained a bachelor of arts from Oklahoma State University and an aesthetics license. She also obtained a bachelor of science in nursing from The University of Oklahoma Health Sciences Center in Tulsa, Oklahoma. Her doctoral residency was obtained at The University of South Alabama, where she focused on the prevention and treatment of obesity, diabetes, and metabolic syndrome and used bio-identical hormone replacement therapy in the prevention of heart disease. Prior to her career in family practice, Lucie had 14 years of experience in the aesthetic industry.