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!!

AGGGHHHHH More Esthecians Trying to Inject Botox and Dermal Fillers

This topic just will NOT go away!!! Where is this coming from all of a sudden. Today, I was minding my own business (admittedly a rarity). I was receiving a far infra red body wrap at a Las Vegas facility. I brought the July issue of Dermascope - a reputable medical aesthetic magazine. I noted an article written by a "medical aesthetician" so that immediately caught my attention because the law does not make the distinction between and esthetician and a medical esthetician. I have blogged about this frequently. In fact, calling yourself that can violate FTC guidelines and state board of cosmetology and medicine mandates. Arguably you are deceiving the public by calling your self that since it is not a higher license and does not allow you to perform additional services.

Then my knickers really got into a bunch when I read the article! The author incorrectly asserts that estheticians can perform ablative laser, dermal filler (Restylane, Collagen, Juvederm) and Botox injections! Hey, folks, I taught at a premier cosmetology school and I can tell you that the depth of knowledge and experience of the vast majority of estheticians is NOT appropriate for these types of treatments. In any event, it is NOT legally supportable for them to do these procedures!! They cannot practice medicine. They cannot dispense prescription drugs or provide medical devices and they cannot operate a laser (except in limited situations). I actually pioneered the ability of esteticians to perform laser hair removal in New Jersey many years ago.

I am actually taking the time and trouble to send Dermascopes editors a letter about this. If enough people read things like this, they will believe that it is acceptable for estheticians to practice medicine.

I do not know where all of this is coming from nor do I know why it is suddenly so prevalent. As I mentioned in an earlier blog, in the past two weeks, I received calls from doctors in Texas, Nevada and Colorado about this. Now, I read this article that would have many believe that estehticians can inject Botox, dermal fillers such as Restylane and Juvederm and perform laser treatments.

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....

Off Label Use

The use of prescription drugs and medical devices in an “off label” manner has been prevalent since the Food & Drug Administration (FDA) first began in 1906. The “off label” use is a reference to physician’s utilizing a prescription drug or medical device in a manner that is different from, or inconsistent with, the FDA clearance for the drug or device. The discussion begins with a brief explanation of the FDA process. The FDA requires a manufacturer, distributor or importer of a medical or cosmetic product or device to obtain “marketing clearance” for the item. In the United States, prescription drugs, medical devices and biologics are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The Food and Drug Administration (FDA) reviews the results of clinical studies to verify the identity, potency, purity, and stability of the "ingredients," and demonstrate that the drug is safe and effective for its intended use.

Upon acceptance that the device or product performs as claimed the FDA issues marketing clearance for the device or product.

There are many misconceptions about the process and results however. In the area of cosmetic surgery and aesthetic medicine, the misconceptions are vitally important. Recently, I have heard more conjecture that the FDA has “no jurisdiction over me” from physicians. They believe that they are able to do whatever they want and utilize any device, product or drug in any manner that they choose because the FDA does not regulate the behavior of physicians.

Technically, this is true. As I mentioned above, the FDA regulates the device, product or drug and not the individual behavior of physicians. However, from a practical and legal standpoint, there is a trend that is concerning. Physicians engaged in cosmetic surgery and aesthetic medicine are utilizing devices and drugs in an “off label” manner with increasing regularity. There are risks associated with this trend and a discussion of risk management is overdue. 

Examples of “off label” uses are Botox® Cosmetic and Sculptra®. Botox® Cosmetic received FDA approval in 2002 for the temporary treatment of moderate to severe frown lines between the brows in people 18 to 65 years of age. Physicians routinely utilize the product for other areas of the body and in patients older than 65 years of age. Sculptra® gained FDA clearance for lipoatrophy in patients with human immune deficiency virus (HIV). It is safe to conclude that the vast majority of cosmetic patients are receiving such treatments for reasons other than lipoatrophy pursuant to HIV.

Recently, I have been contacted by more than half a dozen patients that have received liquid injectible silicone (LIS) treatments in the lips. They have migration, extrusion, and inflammatory responses to the treatments and have health and aesthetic concerns. This brings up the biggest concern over “off label” use of medical devices and drugs: treatments that are not even tangentially related to the FDA clearance and the FDA has never cleared LIS for any cosmetic indication. LIS is approved only for injection into the vitreous cavity of the eye to treat retinal detachment and/or hemorrhage. LIS is intended to help save a person's eyesight and to be aspirated at a later date, once the eye has healed. It is not intended to be kept inside the body indefinitely. However, physicians utilize LIS “off-label” for cosmetic procedures. The FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone, meaning they cannot legally advertise or sell this material, but can legally offer them to customers/patients.

The use of Liquid Injectible Silicone is rising and so is the number of complications. The injection of silicone oil, and many other injectible tissue augmentation fillers, triggers a foreign body response by the accumulation of phagocytes, macrophages, and lymphocytes in the body. The resulting inflammation causes your body to respond by trying to either break it down, by engulfing the product and moving it to other organs for excretion, or essentially encapsulating it from the rest of your body to lessen the irritation effect on your body. The body cannot break down LIS. Since our body cannot break down LIS, the macrophage accumulation triggers fibroblasts to begin encapsulating the LIS, to guard the rest of the body against the irritant. Our body then forms collagen layers around the LIS and eventually augmentation is gained in the form of fibrous tissue. Since the body cannot break down the LIS after encapsulation, it will continue to form more and more collagen around the product and eventually a hard nodule will form around the implant. The good thing about encapsulation is that it can help keep the majority of the LIS where it was injected and hinder its migration into the surrounding tissues. The amount of collagen formed is dependent upon and individual’s unique reaction to the LIS implant so it is difficult to know the degree of augmentation since it will vary from patient to patient.

Physicians must utilize care in the delivery of “off label” products. In fact, it would be prudent to utilize MORE care when utilizing “off label” products than in a typical standard of care for a medical product or service. The trend is for physicians to all but deny the practice of “off label” products and services. I have personally seen the absence of medical charts on many patients treated with LIS for example. This is a precursor to a Board of Medicine violation and potentially a loss of license. Physicians tend to believe that an “off label” use is salacious and should be minimally recognized. The opposite is true and physicians need to exercise more care in the delivery of medical products and procedures in an “off label” use and they need to document the disclosure of information more thoroughly to patients.

Accordingly, if you intend to utilize medical products in an “off label” manner, make certain that you have thoroughly documented the procedure in the chart and include appropriate consents. The consent should include a reference to the fact that you are performing a service utilizing a medical product in an “off label” manner. In other words, the consent should include a statement that either the material or the procedure has not received clearance with the FDA. The more information you provide the better. This can be achieved without alarming the patient and losing the sale of the procedure.

It would also be prudent to discourage payment of cash for the “off label” procedure.  If you do accept cash from a patient, make certain that the cash appears on the practice bank deposits for the day. Also be certain to note that on the daily patient logs etc.  It is too frequent that physicians require cash for an “off label” procedure and this can again lead to intervention by a state board of medicine. The requirement that a patient pay cash for a procedure is prima facie evidence that a physician believes that he or she is performing a legally questionable procedure or that the physician is not reporting the income to the Internal Revenue Service.

A physician that is utilizing products in an “off label” manner must also be careful about the advertising of the procedure. You must always recall that the FDA mostly regulates the marketing of medical and cosmetic products.  Even though they do not necessarily have jurisdiction over a practicing physician, they do have jurisdiction over the marketing of the medical product.  You are able to render your opinion about the effectiveness of a medical product and you are able to discuss the benefits of a medical product, but the further you venture from the underlying FDA clearance, the more care you must utilize in advertising. An example is LIS indicated above. It should not be marketed as a procedure at all since it has not been cleared for any cosmetic purpose.

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!!