Nu U Medical Spas Sued by Illinois AG..Many Med Spas Should Pay Attention

The Illinois Attorney General has filed a lawsuit against Nu U Medical Spas in the Chicago area. The issues presented are remarkably similar to many medical spas owned by non-physicians. This case should be a warning to many in the industry.

The suit alleges that Nu U utilized deceptive marketing and that it is performing unsupervised medical treatments. One of the concerns was over the spas’ use of Lipodissolve to “melt” fat. There are many issues with the use of Lipodissolve but the lawsuit focuses upon the fact that it is not FDA cleared and many organizations such as the American Academy of Dermatology, The American Society for Dermatologic Surgery and the American Society for Plastic Surgery do not condone use of the product. There is little evidence to support its use and a lot of evidence that it does little, if anything.

However, the main issue that I want to discuss is one that affects many medical spas, especially the non-physician owned ones. Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. Many non-physician owned medical spas have non-medical personal injecting dermal fillers such as Botox Cosmetic, Restylane, Juvederm and Collagen without a doctor’s order. In fact, more often than not a doctor does not even see the patient prior to the procedure. In The Nu U matter, the Attorney General found that fact despite its outward claims, Nu U allegedly “fails altogether to monitor and evaluate patients by licensed physicians.”

Another interesting aspect of the case is something that I routinely blog about: The corporate practice of medicine. The Illinois Attorney General argues that the Nu U Medical Spas have violated the Illinois Corporate Practice of Medicine Statute. Forty-five of the fifty states have such statutes and they are violated openly and routinely. These are serious statutes with severe criminal and civil penalties and I am at a loss to figure out why so many violate these statutes on a daily basis. Oops, I do know why…it is called profit!!

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.

The Dentist Hypocrasy

Dentists in several states are petitioning to have non dentists prohibited from performing teeth whitening procedures. On one hand, I can understand this.  Teeth whitening is clearly a dental procedure. The procedure is perfomed in many spas and in physician offices as well.

The American Dental Association (ADA) is petitioning states to enact legislation banning the procedure from non-dental offices. They have been very successful thus far. Twelve states have already enacted legislation limiting the procedures to dental opffices. The legitimate justification for the regulation is the incidence of teeth sensitivity, gum irritation and in extreme cases, trauma to the teeth, gum and enamel. Most of theses problems are transient and the incidence of a true problem is rare.

Here is the hypocrasy: dentists are routinely performing non-dental procedures such as derma fillers (Resylane, Juvederm, etc) and Botox Cosmetic. They are performing laser treatments and hair removal services as well.  The incidence of complication in these procedures is gretaer than in teeth whitenting and the potential side effects are worse. Yet, they are pushing legislation to protect their turf and criticising others, such as dermatologists, who are legitimately protecting their turf.

In my opinion, dentists should be doing teeth whitening and it should not be provided in a spa setting.  However, physicians should be able to perform this procedure.

However, I also believe that dentists should not be doing aesthetic laser, dermal filler and wrinkle relaxers. It is outside the scope of their license, experience and training. I am not talking about maxillo facial doctors and other M.D.'s that practice medicine in and around the mouth and face.  I am talking about true dentists.

I just returned from a business trip to New York and I was appalled at some ads by dentists. Not only did they claim to be "experts" in aesthetic medicine, and not only are they doing these procedures, BUT they are claiming that dentists are the true experts in the delivery of dermal fillers, Botox Cosmetic and other procedures on the face!!! Sorry, guys (and ladies) almost everything that you are doing is dermatology...don't take my word for it...ask the FDA and the ABMS. You are practicing outside the scope of your license!!

Corporate Practice of Medicine Doctrine

This is also known as the “non-corporate practice of medicine doctrine”. Almost every day, I hear some client mention that a consultant built a business model for them and I quickly discover that this well-standing and well-intentioned doctrine has been violated.  The purpose of the doctrine was to prevent non-physicians from controlling or altering our health care delivery system.

 Forty-five out of fifty states prohibit non physicians from owning or operating medical facilities. This includes medical spas or medical practices that engage exclusively in cosmetic, medical procedures.  It may also include laser hair removal centers (this is a complicated situation and will be covered in other blogs). There are limited exclusions to this (such as HMO's).  I do not understand why so many facilities ignore this well-standing premise of law.  In particular, nurses seem to feel that they can own a medical facility and provide treatments since they are fee for service or cosmetic in nature.  Many estheticians seem to believe this as well.  This is a serious and long-standing doctrine of law.  Ignoring it can cause you to lose your license from the state and criminal fines and penalties may be imposed.

The short version of the story is that only physicians can own and operate a medical facility in the forty five out of fifty states (the notable exception is Florida).  Nurses must be employed by such a facility or otherwise contracted with them.  A medical director or supervisor is not enough to enable a nurse to own or operate a medical spa. A medical director or supervisor may not be enough to enable the non-physician to operate a laser, inject dermal fillers (Restylane, Juvederm, etc) or wrinkle relaxers such as Botox Cosmetic.  The reason for this is that lay people… including attorneys, PhD’s and every non-physician…cannot interfere or alter a physician’s “independent medical judgment”. They are to be free to practice medicine in the manner that they deem appropriate outside the business or financial considerations of the corporate (and arguably, governmental) control.

There are legal means in which a nurse and physician may own a medical spa together.  A medical spa is considered to be a medical facility and it must be governed accordingly.

Posted by Paddy Deighan

New Jersey Rules Illustrate Why We Need Restrictions on Cosmetic Procedures

The New Jersey State Board of Dentistry promulgated rules that restrict the delivery of cosmetic procedures by dentists in the State.  New Jersey is known as a "bell weather" state - meaning that other states typically follow legal precedent started in New Jersey.

The new rules state that dentists can do injectable pharmacologics only in the perio-oral area — the gums, cheeks, jaws, lips, oral cavity and associated tissues.  This makes sense as these areas are consistent with the training and experience of dentists.  Predictably, many dentists are outraged by this but the bottom line is that the use of injectables is outside the scope of their license and training.  Procedures such as the wrinkle relaxer Botox Cosmetic, and the dermal fillers such as Juvederm and Restlyane are either prescription (Botox Cosmetic) or a medical device and it is arguably appropriate to limit the use to medical professionals and not dentists.

The new rules are a  bit vague and their are categories of "dentists" that are exempt. For example, maxi lo - facial physicians and oral surgeons are technically medical doctors and not dentists. The term "associated tissue" is also vague.

Many dentists consider the forehead to be an "associated tissue," which would make forehead procedures legal for dentists. Some local dentists in New Jersey, citing their aptitude in the workings of the facial muscles and nerves, say they are more than qualified to offer the treatments.  However, this appears to be a stretch. The "associated tissue" area would preclude the forehead, said Jeff Lamm, spokesman for the Division of Consumer Affairs, which oversees the board of dentistry.

"These are practices of medicine and should be performed by physicians," said Dr. Bruce Brod, a dermatologist and member of the American Academy of Dermatology Association. "This isn't just about doing the procedure but also about making sure there are channels to protect patients if there are complications.

I agree with this new rule since a line must be drawn in the delivery of cosmetic medical procedures and dentists are on the wrong side of the line. However, this rule also illustrates that these procedures are cosmetic medical procedures and they should only b e delivered in medical settings and provided by medical providers.

I feel that regulations should go a step further and regulate the manufacturers such as Allergan (Botox Cosmetic).  There needs to be restrictions on who they can SELL the products to....

Disturbing Trend in the Medical Spa Environment

Many medical spas are turning to various medical, quasi medical and even non-medical personnel in the delivery of medical spa services.  Some of the activities are legally supportable but most are not.

One disturbing trend is the use of non physician injectors.  I categorize this in three ways: Botox Cosmetic; fillers and sclerotherapy.  Botox Cosmetic is a drug and available only by prescription. The manufacturer, Allergan, allows physicians to dispense it in their offices. Contrary to popular belief, it is not directly available to non-physicians, including nurses.  Fillers, are not prescription per se, but they are actually medical devices and as such they are delivered pursuant to the practice of medicine and state and federal guidelines limit the  use and application of these products. These include Hylaform, Restylane and others.

Sclerotherpay is the injection of sclerosing material (saline and others) into a blood vessel to thrombose the vessel and destroy its ability to carry blood and produce unsightly leg veins.  Many states allow Certified medical Assistants to issue injections. Historically, this was for vaccines and such.  Doctors offices could not handle the influx of flu vaccines in the '60's, '70's and '80's so states created this exception to medical practice rules.  recently, many medial assistants wrongfully asserted that they are allowed to inject and have been injecting Botox Cosmetic, fillers and performing vein treatments. This is NOT legally supportable!!