Which Medical Spa Treatments can an Esthetician Perform?

I am frequently asked to comment on the distinction between what is medical and what is aesthetic (non-medical)....the lines are blurry but in my opinion, they are being violated on a daily basis. The practice of medicine is relatively easy to define....it is the diagnosis OR treatment of a medical condition.  Good, bad or indifferent, acne, rosacea, eczema are medical conditions. Some things may not be as clear...for example, treating "razor bumps" MAY not be medical, but on the other hand, those "razor bumps" are Pseudofolliculitis barbae  and then they would be medical. Frustrating...I know.

Additionally, the next level of analysis would be whether any medical device or product is being utilized in the treatment and of so, what federal classification is the device. Virtually all aesthetic lasers AND IPLs are Class II or Class IIb medical devices and they have to be owned and operated by licensed physicians (not RNs). Physicians may, in certain circumstances, delegate "operation" (but not ownership) to other individuals.

Many products are medical...Botox Cosmetic is a prescription drug...100% medical. The dermal fillers (Restylane for example) are all medical PRODUCTS (not a drug). They are still 100% medical but for a different reason.

In laser, you can look at two different types of scenarios...let's use laser hair removal and the treatment of leg veins.  Laser hair removal is NOT a medical procedure. However, if the patient is hirsute because of polycystic ovary syndrome (PCOS), then it IS medical.  In this situation the treatment may not be medical but the device IS medical. Hence, laser hair removal IS medical.

Treatment of leg veins...this is both a medical treatment and a medical device. Two reasons not to perform this service.

With peels, it gets REALLY complex...one analysis would be to look at FDA guidelines. In 1996 the FDA concluded that "medical" is a product that penetrated the epi-dermal/dermal junction. They concluded that a 30% glycolic treatment achieves this. Prior to 1996, they mandated that a 40% glycolic solution achieved this. But what 30% glycolic? pure 30%, neutralized or buffered 30%?...remain unanswered. Soooo, if you utilize a 40% glycolic solution but you know that it is neutralized or buffered, then you are probably OK.

Jessner's peels and most TCA peels are mid-to high level strength peels and they are medical. Sal acid is non medical unless in high strengths....hydro quinones are non medical if they are under 2%...we could go on for hours...topical anesthetics can be medical or non medical too...depending upon the strength and formulation (this is actually a HUGE issue)

The problem is that regulation comes in the form of....state statutes, state and federal case law, federal mandate (FDA, FTC), state boards of medicine, cosmetology and nursing, Attorney General reports and cases...WHEW. There is no ONE place to look!

Recently, there was a discussion and an esthetician commented to me that she contacted her state board in NH. They said that as long as she was certified, it was OK for her to perform the procedure (I do not recall the specific procedure, but on its face, it was medical ...blade or syringe was utilized if I recall). That may have been true by NH board purposes, but federal law would disagree and Federal law trumps state law.

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Physician Delegation Principles in Medical Spas and Aesthetic Medicine

It seems that my blogs regarding esthetician injectors of Botox® Cosmetic and dermal fillers such as Restylane® and Juvéderm® have become a contemptuous topic of conversation. I received a call from a cosmetic surgeon in Texas and this prompted me to further elaborate on the issue that I have presented. Accordingly, I wanted to elaborate.

The first area of explanation is that there is no license in any state for a “medical aesthetician”. It is a term that was created several years ago to identify estheticians working in a medical setting (physician office or hospital). I have advocated that estheticians not utilize the term because it is arguably deceptive. The public (the clients and patients) would likely believe that a person utilizing this term has higher scope of practice and can perform more medically oriented procedures. The Federal Trade Commission (FTC) has addressed issues such as this in the past and it consistently maintains that utilization of such terms is deceptive to the public.

Additionally, in most states, the esthetician license is not recognized in a medical practice or hospital. Most boards of cosmetology maintain that a physician is not the appropriate supervisor for cosmetology. Accordingly, estheticians working in most medical settings are doing so under the physician delegation principles within the particular state.

States have varying regulations on physician delegation. Arguably in some instances and in some states, a physician could delegate any medical procedure to any individual. However, this rationale is based upon state delegation laws. Federal law would prohibit much of the conduct that we are experiencing in the medical aesthetics area. I hesitate to even utilize the term “federal law” in this regard because it is not so much a particular regulation or statute that is a problem. The federal issues are the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) that are at issue. The brief explanation of why estheticians and others are not able to inject Botox Cosmetic and dermal fillers such as Restylane and Juvederm is that in the case of Botox Cosmetic, it is a prescription drug and in the case of the dermal fillers, they are medical devices. Injectors are also utilizing syringes and exposing the patient to a potential for bleeding and these additional issues necessarily mandate that estheticians not inject substances.

Estheticans Cannot Inject Botox Cosmetic or Dermal Fillers

There seems to be a new and disturbing trend in aesthetic medicine. Non-medical providers, and in particular, estheticians, are injecting Botox® Cosmetic in a number of different facilities. In the past month, I have been contacted by three different medical providers in Nevada, Colorado and Texas. They are also injecting dermal fillers such as Restylane and JuveDerm. This is not legally supportable and the activity should stop immediately.

In each scenario, an esthetician was injecting Botox Cosmetic under the loose supervision of a physician (non-core physician, I might add). Apparently, in the respective cases, the physicians maintained that it was lawful for the estheticians to do this under the physician delegation regulations in each state. The rationale was that there was nothing that specifically precluded such practices.

There is nothing in the state regulations that tells estheticians (or physicians) that they cannot perform brain surgery, but we know that they cannot. Injecting Botox Cosmetic is the practice of medicine. There is no question about this and it is not an arguable point. It is not subject to interpretation or subjective beliefs. It is the practice of medicine for several reasons. First, Botox Cosmetic is a prescription drug. Secondly, it is administered via a 30 gauge syringe and it is diluted with saline. An esthetician cannot perform these functions. An esthetician cannot inject anything, including saline. Third, there is no insurance carrier that I am aware of that will provide coverage for an esthetician performing these services. This is clear indication that something is wrong. Fourth, the Board of Cosmetology in the respective states would not permit such conduct. Fifth, the Board of Medicine in the respective states would not permit such activity. There are patient safety, HIPAA and other concerns as well.

In the case of dermal fillers such as Restylane and JuveDerm, these are not prescriptive drugs. However, they are medical devices approved by the FDA and estheticians cannot legally inject them either.

The estheticians in question risk losing their license as well as civil and criminal fines. It is not worth it. The physicians supervising this activity would be subject to reprimand as well.
One of the additional disturbing aspects of this is that Allergan, the manufacturer of Botox Cosmetic, is aware of this and chose to do nothing.