Update on Aesthetic Medical Devices

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance.

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine.

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

Day of Prayer in SOME Schools but Not in the USA

Very interesting.....I do a lot of stem cell research in Russia and Ukraine and a lot of DNA research in Iceland...distressed real estate pays the bills since the grant from the Federal Govt stopped being paid in 2009...anyway....I am planning on being in Urkaine at the end of the month and one of the graduate students commented that I will be there for a day of prayer.

I inquired what that was since I am familiar with most Russian and Ukrainian holidays (and they have a LOT of them-LOL)!! It was explained to me that in their version of elementary school and high school, the students go to school on September 1 and it is called the "day of prayer". They dress in black and white and carry candles to pray for success in the new school year.

I was floored by this since if you tried to do that here, various organizations would file a lawsuit so fast your head would spin around like Linda Blair in the Exorcist.

It is really tragic that people have more freedom in previously Communist countries than we do in many regards. Also realize that they have religious diversity there too...Orthodox, Christian, Jewish, Muslim...pretty much the same mix that we have and yet they are able top come together for a "Day of Prayer" in school. No lawsuits, no bitterness and hatred...traditions honored, not torn apart.



paddy Deighan http://www.homesavers.pro

Deer Placenta as a Nutritional Supplement....OH, PLEASE!!!

Today was another interesting day….a client called and asked my legal and scientific opinion on deer placenta. Apparently, a raw food/vegan guru, David Wolfe is touting it as the next great nutritional supplement. The client indicated that she does seem to have thicker hair and better skin after taking this supplement for over a year. The first clue that this was quackery was that the “nutritional supplement” costs only $60 per month. Placenta extract (let’s call it what they really want to say, “stem cells”) is really expensive to formulate and the conditions under which placenta extract are formulated are extreme. There is no way that a legitimate source of animal placenta extract can be formulated and sold at such a price.

Secondly, why deer placenta?? Websites indicates that deer are a “higher order” animal and that it is appropriate to harvest placenta from such animals for human consumption. Well, folks, sheep is the closest animal genome to the human genome. Porcine (pig) is second. So, why deer??

Third, the FDA regulates any animal extract as a drug and these product s hawked by Ron Teeguarden and David Wolfe are not FDA cleared. The agency would shut them down in a minute if they knew about the claims made for these products. Teeguarden and Wolfe never mention the words “stem cells” because they probably know that the FDA utilizes proprietary software to search for such products. They are trying to avoid scrutiny …and as well they should because they are selling products that would be regulated and they are making outrageous claims.

Fourth, the harvesting of placenta extract is expensive. It requires rapid lyophilization of the tissue almost immediately after extraction. Again, this is costly, time consuming and logistically challenging. I can all but guarantee that these nutritional supplements are not lyophilized.

Finally, and legitimate product that is placenta based, would and should be stored in a cold environment. The stem cells derived from placenta extract cannot get warm or hot. They do not necessarily need to be cold, but they cannot get hot or even warm. The products sold by Teeguarden and Wolfe are shipped in a normal manner and hence, they get warm or hot at some point in the manufacturing or delivery process. Any active cells have been deactivated by the time a consumer ingests the cells.

Save your money folks and do not be sucked in by claims made by pirates such as David Wolfe and Ron Teeguarden.

Paddy Deighan, J.D. PhD

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!!

When May Physicians Introduce New Technology to Patients??

I recently blogged about stem cell applications and it is prudent to discuss an issue that applies to any new medical technology and advancements. The question is: “when can I as a medical provider, introduce new technology, especially if it is not yet FDA cleared”?

This is a very important question. The answer is difficult and there are never any guaranteed correct answers. The law in the USA is typically a moving target. For one thing, the law necessarily lags behind technology (in every aspect of technology – not just medicine). However, medicine is a bit different because we have the FDA to protect patients and provide a process for clearing products and services for treatment. The problem is that it is a time consuming process.

This discussion starts with the fact that the FDA does not have jurisdiction over physicians. It regulates devices and products and the claims that may (or may not) be made about them. The FDA cannot interfere with the physician’s “independent medical judgment”. Accordingly, physicians are free to utilize a product or a device in a manner that they believe will prove beneficial for a patient. They must uphold their Hippocratic Oath to “do no harm” and clearly, the physician should be able to indicate and articulate why the treatment or procedure was performed on a patient.

A physician should study the science and if he or she reasonably concludes that this treatment or product will benefit the patient within the physician independent medical judgment, then it may be acceptable to perform the treatment or procedure. It would also be beneficial to illustrate that peers are doing it as well to help indicate a standard of care for the particular use.

The problem with a new, non-FDA cleared treatment is the marketing of it. The internet has made it easier for patients to find you but it has also made it easier for the FDA to find you! It is tricky and difficult to market new technology, but as I am known to say, “There is always a way!”

Stem Cell Applications: Fact or Fiction

Since I am also a scientist involved in stem cell and DNA applications, many people ask me for guidance on these subjects. There are already many stem cell treatments and applications. There are many valuable treatments with stem cells. There are SOME topical stem cell products that have promise and value. One such product is SCM Forte Many others are hype such as those that are "phyto" based. Folks, "phyto" is plant derived stem cells and there is less than ZERO evidence that these are efficacious in humans. These are shameless attempts to cash in on a trend.

There are many treatments in which stem cells have a lot of promise. There are over 220 applications for stem cells in the human genome. There are three basic ways in which stem cells are introduced to humans: oral capsules, injection intra muscular and injection at point of need/trauma. There are also multiple forms of stems cells - too many to list and the answer to which treatment is best depends upon what you are treating, how the cells were extracted and amplified and the source of the stem cells.

There is a lot of unfounded hype about treatments. I travel frequently and I can tell you that in other countries, people are paying bookoo bucks for worthless treatments. Most of the cells are worthless or not efficacious in the human genome. They also may not have been extracted properly or amplified in a lab properly. There are also many companies and medical practices that are unabashedly thumbing their noses at the FDA as they promote useless treatments and make totally unsubstantiated claims.

There is no question that stem cells will be the next wave of medical breakthrough. The do work and can literally repair anything in the human genome. However, the challenge will be to separate fact from fiction. If you are thinking of incorporating stem cell products or treatments into your center, call me and review the science.

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.

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.

Folks, Estheticians Cannot Inject Botox and Dermal Fillers!!!

There seems to be a massive increase in the number of non-medical personnel injecting Botox® Cosmetic, dermal fillers such as JuveDerm, Collagen, Perlane, Hylaform and Restylane. There is a correspondingly huge increase in the arrogance with which such providers are maintaining that they are allowed to do this. In the past two weeks, I received contacts from physicians in New Jersey, Texas, Colorado, California and Nevada about the issue of estheticians injecting Botox® Cosmetic.
The argument that they are allowed to do this is that they are doing so under supervision of a physician. IF this is legally supportable, the non-medical personnel would have to be DIRECTLY employed by the physician and properly supervised by the physician. Remember that I stated “IF” this is legally supportable. Other times they are stating that the physician can DELEGATE this to the non-medical personnel. Again, “IF” this is legally supportable (and it isn’t), the injector would have to be directly employed by the physician and supervised by the physician. Additionally, it would be far more preferable if the injector was NOT and Independent Contractor of the physician. He or she should be an employee.
Realize that there are many issues presented here- not the least of which is insurance coverage. If an esthetician injects Botox® Cosmetic , Collagen, Restylane, Perlane, Hylaform, Juvederm etc., there is NO insurance coverage for this procedure!!
Another issue is that the esthetician license is frequently not recognized in the medical office. Accordingly, the esthetician is an unlicensed non-medical person performing medical treatments. Even in situations in which the esthetician license is recognized in a medical office, the scope of their license NEVER allows them to inject Botox® Cosmetic or dermal fillers.
So, let’s sum this up…non-medical personnel are injecting prescription drugs and medical devices through a syringe and there is no professional negligence coverage; and they are doing so outside the scope of their license. This is OK??? Really?? Guess what…it isn’t OK….for the simple reason that they are engaged in the “UNAUTHORIZED PRACTICE OF MEDICINE”!!!!! EVERY state prohibits this! EVERY STATE! The state Attorney General can prosecute such cases..wanna go there??? 

Non-Physician Owned Medical Spas

It is really frustrating to see soooo many medical spas violating basic state and federal laws. I had occasion to visit a medspa in Las Vegas this week. I was SHOCKED at the number of state and federal violations I noticed. Medical assistants injecting Botox® cosmetic, non-licensed individuals operating a laser, equipment not available in the USA, and a “supervising” physician that has never been on the site!! In fact, a medical assistant should not be employed in that capacity by a non-physician owned medical spa!! It amazes me that there is so much clear violation of so many laws and the arrogance of those that defend the un-defendable when approached with the issues.
Compliance is on the rise and states, the FDA and other federal agencies are becoming more aware of the issues. Physicians are more aware of the duties and responsibilities of being a medical director or in medically supervising another facility.
Folks, it is time to wake up and appreciate that a non-physician owned medical spa is a huge concern, It is very difficult for such facilities to operate in any manner of compliance. They are called “medical” spas for a reason. I am not saying that it is impossible; but it is problematic!! Websites frequently provide so much information of violations that regulators would not even have to visit the site! Websites and advertising are the biggest source of compliance triggers. The facility that I visited this week had CLEAR indication that the physician was the owner of the medical spa!! AS I mentioned, the physician had never even been on the site!! Peer complaints are next – many of your peers will complain to the boards of cosmetology or medicine. The boards, by charter, must investigate EVERY complaint – no matter how deficient on its face. The cost of defending a compliance audit is HUGE and the fines and penalties are high. There is even criminal prosecution and loss of professional license possibilities. Yes, this does happen!!

Part III of Issues Regarding the Resale Laser Market

This final blog in the resale laser market segment focuses on two related issues: Laser manufacturers’ refusal to service lasers and light based medical equipment sold on the resale market an restrictions on who may repair/service a medical aesthetic laser.

These policies and restrictions are violative of the restraint of trade provisions of the Sherman Anti-Trust Act and the Uniform Commercial Code. In many instances, an owner of a medical aesthetic laser or light device cannot obtain service on the device or they are able to obtain service but it is at an exorbitant price and discriminatory as indicated in the above discussion. In other instances, the owner of the device can get service, but the service technician is unable to obtain a needed part in order to repair the laser.

These policies violate the Sherman Act and/or the UCC and Robinson-Patman Act. An analogy would be that an owner of a used BMW cannot get service at a BMW dealership because they are not the original owner. Another analogy would be that a repair facility of choice cannot repair a BMW because the manufacturer will not provide the needed part for an arbitrary or less than legitimate business purpose. A third analogy would be that a BMW dealership has different parts or service pricing depending upon whether you are the original owner.

In all of these analogies, the conduct would violate the spirit and intent of the respective federal laws. Laser manufacturers are violating these concepts frequently and in most instances in which an owner is unable to purchase service or parts, or may otherwise do so at pricing levels higher than original owners.

I will conclude these issues by indicating that there are legitimate times when laser manufacturers refuse service or parts and I acknowledge this. However, there are far too many instances when the state and federal laws are violated without legitimate validation.
I would also like to indicate that many of the policies of laser manufacturers violate the financing agreements by and between the owner and the funding source for the acquisition. This is especially true when the manufacturer arranged for financing.

Finally, there are many state laws that would protect owners of aesthetic medical lasers. It is not possible to discuss all of these

Part II of a Review of the Resale (Used) Laser Issues

In regard to discriminatory pricing of laser parts and service, it has been customary for laser manufacturers and their suppliers to charge substantially different pricing to owners of resale medical aesthetic laser devices and other individuals and business entities. In my experience, I have noticed that same part have a cost of $100 to an original owner of a device, and a cost of $400 or more to a device owner that is not the original owner. This is not legally supportable. There appears to be wide-spread discriminatory pricing in the resale laser market.
The issue presented here is the anti-discrimination policies under Federal law. The Robinson-Patman Act of 1936 amended prior legislation to prohibit certain anti discriminatory practices of large businesses relative to smaller businesses. The Robinson-Patman Act is complex legislation and there are certainly situations in which pricing variations are legitimate and legally supportable. For example, if a buyer is purchasing in bulk, it would be expected that they receive volume pricing. A wholesaler would also expect to receive better pricing. However, in my experience, the activities of many laser manufacturers in this regard are clearly violative of the spirit and intent of the Act. There is no legitimate justification for the price variance that I have observed. The amount of variance is not justifiable.
There are also situations in this issue that may also violate the Uniform Commercial Code as adopted in all 50 states. It is difficult to discuss this in this forum because each state has adopted its own version of the UCC. It is important to note that the UCC, as adopted in each state, will have protections against this behavior as well.
Also, in regard to pricing of laser parts, in many instances the laser manufacturers will not supply parts to technician at any price. I am going to discuss this tomorrow in the third blog about used (resale) lasers.

A Discussion of Laser Manufacturer Issues Relating to Used Lasers

There are numerous issues relating to the purchase and operation of medical aesthetic lasers on the resale market. This blog will serve as a general purpose letter to address the issues and provide a legal framework to resolve such issues. It is impractical and legally impossible to address specific issues relative to specific situations since the resolution of many medical aesthetic laser issues involves varying state and federal law as well as differing policies among laser vendors, laser manufacturers, purchasers, financing sources and state law. Each situation is unique and requires review and consideration of the principals discussed herein. The length is such that I will post this in three separate blogs.
Some background information is also necessary to provide additional insight into this opinion letter. I have been directly involved in the aesthetic laser industry for almost 20 years. My experience includes serving as general counsel to two laser manufacturers and as a consultant to a third. I have also served as CEO of a large dermatology and plastic surgery network and we directly or indirectly purchased literally thousands of aesthetic lasers and medical light based equipment. I have been an attorney for over 25 years and have multiple graduate and doctorate degrees in science as well.
The areas of focus of this letter are based in three issues:

1. Laser manufacturer requirement of certification of resale lasers;
2. Laser manufacturers’ arguably discriminatory pricing for parts;
3. Laser manufacturers’ refusal to service lasers and light based medical equipment sold on the resale market.
4. Restrictions on who may repair/service a medical aesthetic laser.

The certification requirement centers on an industry policy that mandates that a purchaser of “used” medical aesthetic laser must have the device certified in order for it to be repaired or serviced at a later date. Frequently, such certification comes at a very expensive price. Although this is a valid and legitimate business interest of the laser companies, the implementation of the legitimate polices is legally unsupportable in most instances.

The reason that many of such policies are not legally supportable is that such policies are arguably in restraint of trade and subject to review of the Sherman Anti-Trust Act. It is arguably restraint of trade to charge disproportionately high fees relative to the acquisition price of an aesthetic medical laser. Laser manufacturers charge varying fees for “certification” when in fact, the certification process is largely the same for most devices. The certification process entails inspection of the device in order to determine whether it has been altered, modified or otherwise changed from its original configuration. This certification process may also necessarily include inspection of computerized or automated sub systems of the device, such as a computerized scanner.

The prices charged for this service are frequently outrageous given the time and expense involved in the process. As I stated above, this is a legitimate business interest and concern for the laser manufacturer. However, they are charging exorbitant and inconsistent fees for this service. Since the certification is necessary in order for the new owner to service or maintain the device, then buyer is at a competitive disadvantage in such transactions. This situation requires that laser manufacturers avoid appearance of tactics that rise to the level of restraint of trade. It has also been my experience that laser manufactures will waive or reduce the certification fee arbitrarily and also in violation of the laws intended to protect such situations.
The Sherman Anti-Trust Act of 1890 is designed to prevent monopolistic trade practices and anti-competitive business behavior. The certification requirement is a legitimate business interest. However, the fees charged in many/most instances are violative of the spirit and intention of the Act. Many laser manufacturers have even restricted or prohibited its suppliers and vendors from supplying the parts and services to owners of resold medical aesthetic lasers. However, this right must be asserted by the supplier or vendor, but it does merit mentioning.
In fact, one prominent laser manufacturer suffered a decrease in its stock price in 2008 because analysts were concerned about restraint of trade issues.
Additionally, the certification raises issues under the Uniform Commercial Code (UCC). Many of the certification policies will violate the intent and spirit of the Uniform Commercial Code, especially Article 2 of the Code governing Sales. A more thorough discussion of this issue is not practical under the UCC because all 50 states have adopted the UCC in some form, but there are differences from state to state. However, it is important to note that in many of the certification issues that I have encountered (many), the UCC in its adopted form in various states, has been violated.

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.

Ya Wanna Know What is Wrong with Health Care in America??

A friend is having surgery so i asked if there is anything that I can do! The response was that a prescription needed to be picked up for post surgical protocol. OK, no problem, I will pick it up. Well it seems that there was a problem with the insurance card. Pharmacist claimed that a new card was issued for the patient.

OK, that was the FIRST problem. The prescription was renewed online 12 hours earlier yet no one from the pharmacy bothered to call and see if the plan member had received a new card.

I get to the 24 hour CVS and the pharmacist tells me that he cannot get an approval because a new insurance card had been issued. Great! It is 1 AM and I dare not call the patient who is getting up in 3 hours.

Well, I thought that I would ask..."how much is the prescription". Pharmacist replies, $11.99! Great, I will just pay for it! WELL, that started a 20 minute debacle. Changing something int eh computer...RE-FILLING the prescription (WHY??). Pharmacist returns with the prescription and I HAD to ask..."how much would the co-pay have been?? He replied, "$15". THAT is what is wrong with health care in this country. Exhibit A. Not to mention that the pharmacist stated that this happens all of the time!!! Great!

Stem Cells, DNA and Smoking in the Sauna

Those that know me are aware that I also have a PhD and work in DNA and stem cell research. I am helping us to live a longer, healthier life. In fact, the human genome has a genetic lifespan of at least 150 - 200 years and we have enough stem cells for us to live to be 1,000 years old. Biblical accounts of humans living that long may not be fodder after all (Methuselah for example). Many cultures have stories about a super/warrior race that was 8-10 feet tall and lived very long lives. In my opinion, these warrior races were humans with overly active stem cells. I have already worked on a project that has taken hundreds off of the knee replacement list via stem cell treatments. I have also helped to develop a stem cell mask which has had an amazing impact on those that have used it...younger skin..disappearance of age spots etc.

Anyway, I digress a bit. Tonight I went to the swimming pool and hot tub and then I went to the fitness center. I am in Las Vegas this week and smoking is tolerated in most areas here. However, while minding my own business and listening to some tunes in the sauna...a gentleman came in SMOKING A CIGARETTE! I politely and slowly removed my headset and asked him to extinguish the cancer stick. HE REFUSED mumbling something about being able to do whatever he wants because this is Vegas!! This is where being 6'4", 275 lbs. and from NEW JERSEY comes in handy.

I stood up... took the cigarette from his hand and extinguished it on his forehead!!! Then I mumbled something about being able to do whatever I want because this is Vegas! Poor bastard still doesn't know what happened! LOL. Smoking a cigarette in a sauna....a new high in lows!

Chart Issues in a Medical Spa...Who Owns the Chart??

The traditional “rules” of medical practice medical charts are not adequate in the modern age of aesthetic medicine.
There are two issues that have been misinterpreted and misunderstood. The first issue is who “owns” the patient chart. The second issue is under what circumstances should a practice maintain two sets of charts or records. There is no question that the “cosmetic” patient is more challenging in terms of results, satisfaction and “hand holding”. Consequently, more cosmetic patients leave a practice and request their medical records. There are also more medical professionals leaving a practice to work in another facility and battles over the charts have become common and emotional.
The discussion must begin with a common misconception. The practice or the doctor does NOT own the medical chart. The patient “owns” his or her medical chart. The doctor or practice is merely the custodian of the chart or record. Accordingly, when a patient requests a chart, you MUST provide it to them. It is prudent to give the patient the original chart if they request it and keep a copy in the practice to coordinate care and maintain records as required by state and federal law. It is appropriate to charge a fee for the chart, but the fee should rarely exceed twenty-five dollars.
It is also acceptable and advisable to have the patient sign a release for the chart. The release should direct where the chart is going (even if it is to the patient) and it should be plain language The release should only reference the chart and a release of liability for the transfer of the chart to the patient or other facility.
Many patients receive services from several different aesthetic and medical providers within the same practice. Accordingly, there is substantial confusion over the entire chart documentation process and there are more issues than it initially appears.
The question of whether to have two sets of charts is itself complicated. Some additional considerations further complicate the issue. Some practices have one chart for all services while others have separate charts for medical and non-medical services. Practices have valid justification for their policies in both instances.
The answer of which protocol is more acceptable is difficult to answer and clarification comes in the form of a middle ground that can keep all practices safe and compliant. It is prudent to maintain two sets of patient records; one for the medical procedures and the other for esthetic or non medical services performed within the facility. However, it is also prudent to keep the two sets of records together and color coded. For example, the medical charts may be the traditional manila charts. However, the non-medical chart should be a different color and all of the non medical services kept in the colored chart. This will enable easy removal by an esthetic provider (to provide a service) without disruption of the chart. It is also important to do keep charts in this manner because patients do not “own” the esthetic chart and if they request their medical records, you may not want to copy and provide the esthetic chart for non medical services (such as laser hair removal and superficial peels).
This is a significant distinction because when an esthetic provider (non-medical services) leaves the practice, they will frequently take the “charts” or the records so your employment agreement with them must address this occurrence. If they do not take the actual chart, he or she may take the information and contact the “clients” and you may not desire this so the employment agreement must address this too.
Keeping two sets of records but in one file will also coordinate care. Many “esthetic” procedures are at the direction of the medical provider. A good example would be acne patients that are receiving glycolic peels for oil control. The medical provider may want to review the peel history during medical treatment evaluation so access to the record is important. Laser hair removal may also be another good example since many patients are treated medically for burns, hyper and hypo pigmentation.
This issue is complicated when the non-medical services are performed in a separate facility that may have common ownership with the medical practice. I will discuss this in the next blog.
There have been many recent questions regarding medical and non-medical providers leaving a practice and trying to take medical records with them. In the event that a non-medical provider (such as an esthetician) desires to leave and take the charts, a policy should be in place in the practice for such occurrences and it should be anticipated and addressed in the employment agreement as well. A practice does not have the argument that the chart must remain in the practice because they are the custodian of it since the patient does not “own” the chart and the practice is not the custodian of the esthetic records.

A Real Estate Career Alternative: Real Estate Appraiser

Probably one of the most well-known but seldom talked about careers in real estate is that of a real estate appraiser. Appraisers provide professional, objective opinions about the market value of a piece of real estate. There are many reasons to get an appraisal, including if a property owner wants to obtain a loan, change their property taxes, insure a property, settle an estate, establish value or, of course, sell their property. In order for an appraisal to be useful, it must, ultimately, “reflect a credible estimate of value”. Appraisers are responsible for identifying the end-users of the appraisal, including who requested the appraisal, as well as the intended use and the purpose of the report. They also must include a full description of the property including location attributes, physical attributes, legal attributes and economic attributes as well as easements, restrictions, encumbrances, leases, reservations, covenants, contracts, declarations, special assessments, ordinances and division of interest in the property. All of these items and many other small details are used to create as comprehensive a picture of the value of the property as possible.

By now, being an appraiser probably sounds like a pretty interesting job, but it is also probably clear that you need an attention to detail. Appraisers must be certified in the state in which they wish to work and may work for corporations or individuals. Presently, there are many new restrictions on appraisers thanks to the real estate market crash, so make sure that if you decide to become involved in this business you understand exactly how, for whom and in what capacity you can legally work. Real estate appraisers can be salaried or work on contract or commission. They can make more than $100,000 a year and often work flexible but long hours. There is a higher demand for real estate appraisers than ever and there will be a lot more work in the future. Most appraisers are pretty busy today so be patient with them!

The Use of Titles and Certifications in Aesthetic Medicine

There is an increasing tendency for individuals in aesthetic medicine to utilize titles, designations or certifications in their marketing and daily practice. There has been a corresponding increase in complaints to medical boards, boards of cosmetology and FTC regarding this issue so it is a good time to review the issues.

Many providers receive a license from a state governing board. This governing board provides “scope of license” parameters and these should always be strictly followed. You should never advertise, in any manner, proficiency beyond the scope of license granted top you. You should never indicate or advertise additional proficiency beyond the license that the state granted you. The reason is simple: it is deceitful to the public and advertising proficiency in something beyond the scope of license can result in loss of license and momentary fine. In some situations, it can also be criminally actionable against you.

There are many examples that I notice on a daily basis: a physician advertising that he or she is “board certified” and neglecting to mention in what specialization board. For example, an aesthetic medical provider that is providing laser and dermal fillers should not indicate that they are “board certified” without also mentioning by which board. The reason is that this practice may be deceiving the public and the Federal Trade Commission (FTC) and state board of medicine will take action against such physicians. It is deceitful (arguably) because the physician may be board certified in something that has nothing to do with dermal fillers or laser (which are under the specialty of dermatology).

Another example relevant to physicians is the use of ancillary organizations which are not part of the American Board¬¬¬¬ of Medical Specialties. Membership in the American Academy of Cosmetic Surgery for example does not make you board certified in cosmetic surgery and many advertisements convey this message. Not only will state medical boards and the FTC have a problem with this, but an astute lawyer in a professional negligence action will as well.

In a similar manner, aestheticians, nurses, technicians, etc. should not advertise credentials beyond the scope of their license or training. There is no such thing as a “medical esthetician” or “para medical esthetician” for example. True, you may have received additional training but this does not enable you to perform additional services beyond the scope of your license and it does not mean that you can refer to yourself as such. The issue again is deception of the public. There is seldom a designation for “Certified Laser Technician” either and in many instances, such designation refers to individuals that REPAIR lasers not operate them. Again, the additional training is commendable, but it does not enable a provider to advertise or describe themselves in any manner that expands or alters the scope of their license or the use of medical devices as a designee of a physician.

Compliance in these areas is on the rise. Complaints by peers and clients and patients are on the rise as is professional negligence claim so be prudent when marketing your skills and training!!

An Update on Laser and Who May Operate a Laser

There is one area of aesthetic medicine that seems to be misunderstood and the subject of a lot of misinformation. Lasers and other light sources have been the subject of a lot of debate since the early 1990’s when the aesthetic use of laser began with the introduction of the CO2 laser. There also seems to be waves of misunderstanding regarding these devices and it appears that we are in another such wave. The development of new lasers and light-based devices that are non-ablative seem to have brought this issue to the forefront again.

The questions that we are frequently asked revolve around who can operate a laser. Before we address that issue, it is prudent to address the more global issue: Who can own and operate a laser?

Most (if not virtually all) efficacious aesthetic lasers are federally classified medical devices. They are classified such that they must be owned and operated by a physician since they are classified as medical devices. Yes, there are some devices that are classified as medical but are available to other professionals (some LED). These devices are the exception to this principle. Most of the devices must be acquired by a physician and the physician is then free to delegate the use of the device to some in his or her office. Others should only be utilized by the physician.

One of the confusing issues is the dichotomy of state and federal law. Generally speaking, federal law takes precedence over state law on a particular subject matter if both state and the federal government have regulated such area. An exception to this general principle is whenever the state law is more strict. Again, it is federal law that classifies the devices and state laws have varying additional regulations about who and under what circumstances may utilize such devices.

The question of who can acquire a laser is clearer than who may operate it and under what circumstances. The moment a physician allows someone else to perform the treatments, a whole litany of issues arise. The first issue would be what is the non-physician treating? There may be a difference between light based hair removal and treating a medical condition. It is clear that only a physician or appropriate allied health provider can make a medical diagnosis. This cannot be delegated by a physician. For example, someone operating a laser or light device cannot assess that a patient has acne and then treat them for acne under an established protocol.
Accordingly, it would be prudent to have the physician make a medical diagnosis prior to treatment. In any case, it is better protocol to allow the physician to see that patient prior to treatment.

The second issue would be where the procedure can be performed. Whenever the location of treatment is anywhere other than the physician’s office, there will be scrutiny of the relationship between the physician sand the owner or tenant of the other location. This is a complicated issue and it will vary from state to state. There are medical supervisory issues as well as delegation issues and fee splitting issues of state and federal law.
The third issue would be who is performing the treatment. The ability of someone other than a physician to operate a laser is based upon the concept that physicians are free to delegate the treatment plan to non-physicians to provide better and faster care to patients. Such concepts were developed long before the aesthetic use of light devices and in limited situations; they have not been modified to reflect delegation of light-based treatments.
Historically, physicians began delegating laser to existing office personnel. Some states began enacting legislation that limited a physician’s ability to do this. Again, this varies from state to state so we can only discuss general concepts. It would be prudent for a physician to delegate to medical personnel. The further you get away from medical personnel, the more risk there is to being noncompliant. Estheticians are not medical personnel and although some have “para” medical esthetician training, they are not considered medical personnel and their licensure is governed by a state board of cosmetology. It can be argued that non-medical staff can perform purely aesthetic procedures such as laser hair removal or tattoo removal. In such cases, bear in mind that the devices being utilized are still federally classified as medical devices and the use (and ownership) may be limited by that concept. Consideration should also be given to the location of the treatment and the best case scenario would be in the office of the physician that acquired the device.
The fourth issue would be under what circumstances the procedure is being performed. The safest location would be within the office of the physician that acquired the device. Removing the procedure from that office triggers the issues stated above. The availability of the acquiring physician to be present during treatment is also a significant issue. However, it should be noted that a medical procedure should always be performed in a medical facility. I should not have to state this, but a spa is not a medical facility. A non-physician owned “medical spa” is also not a medical facility.
Another issue that relates to the circumstances surrounding a treatment is where the after care is being administered. This is medical regardless of the procedure since the issues are frequently burning, hypo or hyper pigmentation and general wound healing. Non-medical personnel may make an initial review and listen to the patient’s concerns. The minute that there is any irregularity or subjective complaint from the patient, a physician or appropriate medical provider should be brought in to manage the patient care. There may be other idiosyncratic reactions and these would be classified as medical too.
Written protocols are another circumstances issue. Any physician should have clear and written protocols for each type of procedure being performed within his or her office or outside of it if the physician is allowing such treatments to be performed under his or her license. The absence of written protocols will be very damaging in any lawsuit brought by a patient or governmental compliance audit.
Such protocols should be thorough and clear. Procedures should be implemented to regulate adherence to the protocols as well. The fact is that many of the issues discussed in this article and others that relate to the topic are subjective and within a “gray” area of the law. This is done purposely by legislatures as the technology always leads the law. The law reacts to technology and tries to anticipate future changes. Since much of the regulatory and liability claims are subjective, the written protocols are critical as I have seen that the mere existence of them has terminated investigations.
It should also be noted that I have seen abuses of these concepts in the devices being utilized to treat fat or cellulite. There is misconception that these are not medical devices and I have seen them in far too many spas. The original device FDA cleared in the United States was Endermolgie in 1996. It is acceptable as a non medical device as long as the claims being made regarding the results are in FDA compliance. However, the newer generation products also contain a light-based component and most of these devices are federally classified as medical devices.
A final note that should also go without stating is that many laser companies will sell anyone a laser. I have been known to say that they would sell a laser to my dog Stoli if he ponied up the money! I have also heard too many times that the laser company has a letter from an attorney or the FDA allowing the sale to a non-physician. After 17 years of doing this, I am still waiting to see this mystery letter.

An Explanation of the FDA Process....

I had a call from a client last evening. He is from the raw food/vegan world and a believer in holistic cures whenever possible. He inquired about a product utilized to promote reduction in mercury levels in humans. He indicated the he could no longer get the product because the FDA will not allow its sale. The predictable rant about the FDA and how they are ruining cures...you can imagine.

Many do not seem to understand that the FDA does not "approve" products for medical uses. They "clear" them for marketing after the manufacturer has proven that the claims that will be made can be substantiated and medically/scientifically proven.

I did some research into this product and it was not the product itself that proved to be a problem for the FDA, it was the claims that the manufacturer was making. The claims may well have been legitimate but there was no proof...no independent validation.

The FDA is not a governmental agency hell bent on destroying holistic medicine. It is here to protect us from unsubstantiated claims. Do we want the days of snake oil salesman to return?? Ohhh, wait, there are a ton of snake oil salesman today!! LOL

I am not defending or promoting the FDA. There are plenty of times that I disagree with them either as a scientist or an attorney. Recently in fact, I strongly disagreed with a position of an examiner and we talked about it and he saw that my points were valid.

If you are going to make claims about efficacy of a product that is utilized to cure, prevent or maintain and illness, you better seek FDA clearance...

More than a Few are Practicing Medicine without a License

Virtually every day, there is a a story relayed to me by a client, patient, or medical provider in which a person received questionable "advice" from a "practitioner". There are FAR too many non-physicians practicing medicine. The simplistic version of the practice of medicine is the diagnosing or treating medical conditions. It would also include the use of medical devices.

Today, I was on a conference call and one of the participants was relaying the story of a medical condition that had recently become more of a problem. The comments were made in passing and the individual was explaining why there was a delay in responding to a prior conference call.

It was a fairly serious medical condition. One of the conference call attendees proceeded to diagnose what the problem was and recommend a homeopathic remedy. I was very familiar with the "theory" behind the remedy. However, I was also aware that this proposed "remedy" had potentially dangerous side effects and that there is NO medical or scientific evidence to support its use in this situation.

I intervened and was told that I do not know what I am talking about and that allopathic doctors receive one hour of nutritional training so they do not know anything. I was compelled to illustrate that I have two doctorates and I would not have made the statement that the "practitioner" made. The "practitioner" had all of a high school diploma and little to no health training. I also was compelled to indicate that she was not a nutritionist.

There are colon hydro therapists, herbalists, personal chefs, juicing advocates, raw food enthusiasts, estheticians and many others that are practicing medicine every day. The more alarming thing is that there are MANY people that jeopardize their health by listening to these people. There are so many websites, blogs, webinars, retreats, etc being promoted by those of dubious credentials, knowledge and experience...all vying for a piece of the pie.

I am not suggesting that there is a lot of merit to many homeopathic concepts...I worked as a consultant with the Grand Father of Complimentary and Alternative Medicine (CAM) in the United States, Robert Atkins M.D. I saw first handed how such such remedies can be beneficial and save lives. However, there is a lot of ...for lack of a better term..."quackery" going on.

Actually, the most alarming this is that states are not doing anything about it on any concerted level.

An Emerging and Disturbing Trend in Medical Spas....

For those that follow the medical spa industry, there is always a new product or service that is being touted as the latest and greatest in the industry. Many are little more than marketing hype.

One emerging trend is the hCG diet. Supporters argue that it has allowed many to lose weight. Others maintain that there is no scientific evidence that indicates that it is effective. They further opine that any weight loss is a result of near starvation diet levels of calorie intake (less than 500 calories per day).

hCG is human chorionic gonadotrophin and it is a pregnancy hormone. It is non existent in the male anatomy except for a brief period after birth. It only exists on women during pregnancy. It use is linked to near starvation diets in the weight loss use.

It is important to note that its use is not FDA cleared. By itself, this is not a concern because physicians routinely utilize medical and prescriptive materials "off label" if they believe that it is warranted in a given situation.

However, it is appearing in many non-physician owned medical spas. The HCG dispensed in such settings cannot be medical grade hCG and popular belief is that the non medical grade hCG is non efficacious for weight loss. In fact, in January of 2011, the FDA determined that homeopathic hCG is "fraudulent and illegal" when sold for weight loss. Even in a medical setting, with physicians utilizing medical grade hCG, the product must carry a warning which indicates that there's no proof they accelerate weight loss, redistribute fat, or numb the hunger and discomfort typical of a low-calorie diet.

The bottom line is that there is no scientific evidence to suggest that hCG works.

The disturbing thing is that I have noticed many medical spas that are touting outrageous results from the use of hCG. It appears that many spas are promoting hCG without differentiating between homeopathic grade and medical grade.

In any event, the use of such a product must be carefully watched. Practitioners need to exercise extreme care in providing this service. Extreme caution must be made in marketing the service. From what I have observed, there are a lot of fraudulent claims that may result in severe damage to patients and client...

Another Reason that the Medical Spa Business is SOOO Difficult

One of the challenges that I have routinely encountered is that there is another attorney involved in a medical spa matter and he or she does not know the legal nuances of the industry. Recently, I had an attorney that was resisting a critical course of action for a medical spa.

The attorney was not well versed in these areas and kept requesting support for my position on HIPAA. She wanted me to show her where it is necessary to include a Business Associate Agreement in a medical spa setting. This is a basic thing for a medical spa and it is not written anywhere that "medical spa, you must do this". The law does not work that way in this country. It is subject to interpretation. however, this was a basic tenet of medical spa law.

It is difficult to sometimes say why something is "necessary" in this area of law. In this instance it was prudent to complete a Business Associate Agreement (BAA). My argument then became, "there is NO harm in completing a BAA, and potentially tremendous harm in NOT executing one, so why not complete one"?? More resistance.

There are two basic lessons here...first, realize that when an attorney, in any area of law, is unfamiliar with a particular issue, they will reject it and say no because they are not comfortable in agreeing with the position on the issue.

Second, always entrust your counsel and guidance to an attorney that is well versed in the issues you face. All too frequently, I get referred to someone's "attorney" in a complicated business matter and it turns out that the attorney handled a personal injury claim for them!!

FDA's New Agressive Policies on Websites and Skin Care

Recently, I have had several clients receive warning letters from the FDA regarding their websites or retail skin care products.

In regard to websites, the FDA makes various claims that the particular sites are making unsubstantiated claims regarding efficacy of products and services. In each cases, I strongly disagree with the FDA. In one instance, the website merely stated that a procedure "lessened the appearance of wrinkles". Those are appropriate words for an appropriate procedures.

In other website issues, the FDA is claiming that the procedure was not cleared for marketing of the respective procedure. This is ludicrous to me beause a physician can claim whatyever they want to - the FDA has no jurisdiction over them and their independent medical judgment. A physician can claim whatever they want, but they cannot claim that it is "FDA approved". This is a misnomer anyway as the FDA does not "approve" anything.

In regard to skin care, the FDA is cracking down on physicians that compound and offer prescription strength products in an over the counter format. They are also concerned with claims about claims made in skin care. In one example, the product merely claimed to "hydrate" the skin. The FDA had a problem with this?? The product contained hyaluronic acid which is agruably nature's best emollient since it binds to water and retains 1000 times its molecular weight in water. It is more than fair to say that it "hydrates" the skin.

In yet another skin care example, the FDA took exception to a clain that the product softened the appearance of wrinkles. What is wrong with that?? If they are going to start enforcing such language, there will be no marketing on any product. Cosmetics make far more medical claims every day in TV and print ads.

The point is that the FDA appears to be embarking on a course to strictly enforce its policies - to the point of over-stepping their bounds...

The Importance of Reviewing Leases for Medical Spas

Leases are rarely considered an important aspect of medical spa issues. However, I have had numerous instances where a lease became a major problem; and others in which it helped alleviate a problem. Many lease related issues arise but the most important is the "intended use" provision of the lease.

A medical spa should be considered a medical facility even if it is non-physician owned. Accordingly, the use and zoning should be appropriate for a medical practice. This is not a minor issue. Medical zoning is typically such that there are certain areas of a municipality that are zoned for medical use. There are parking issues, handicap parking issues and electric and plumbing issues.

There are also "exclusive" use issues that pertain to most medical spas. Skin care is a frequent issue. Occasionally, there will be an existing tenant that has an exclusive right to retail skin care. This would prohibit you from retailing skin care in your space. Therefore, it is essential to identify to the landlord the totality of your business and ask whether there are any "exclusive use" issues with existing tenants.

I was contacted this week by a spa that has an exclusive use issue with a SHOE STORE!! The shoe store had the exclusive use for MASSAGE! The spa may have to locate to a new facility!!

Bin Laden Cover Up

OK, I will go on record as saying that I believe that Bin Laden is dead.....BUT (and you heard it first here)...there is a massive amount of bullshit surrounding his "death" and we are not being told the truth. A lot hapopened in a twelve hour period - they killed him, ran DNA to confirm death, took NO PICTURES of the dead body...got him to the USS Vinson thousands of miles away and performed a Muslim burial at sea...ALL WITHIN TWELVE HOURS???? C'mon. First of all, they did not run DNA in twelve hours.....and where did they get a sample of his DNA to run against??

This reminds me of a story of my beloved Portia....one day she returned home with a dead squirrel in her mouth...joyously proclaiming that she was responsible for the rodent's demise...upon brief inspection, I noted that the aforementioned squirrel had tire tracks over its body...I told the dog that it was already dead when she captured it ..so no victory here.


The analogy?? Bin laden is dead...the US is taking credit but there is a lot more to this story.....we are being deceived for a little change of pace...

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

Interesting Question Asked of Me....

I recently wrote a blog about laser hair removal and how it relates to the practice of medicine.  I received feedback about  this blog and I was asked..."if laser hair removal is not the practice of medicine, is laser (and light based) tattoo removal the practice of medicne".

This actually has the same answer...light based tattoo removal is not the diagnosis or treatment of a medical ciondition, so it is not the practice of medicine.  However, the light sources utilized ARE medical devices and they are federally classified.  Tattoo removal can be achieved with lasers or IPL (Intense Pulsed Light) sources.   A laser is a Class IIIb or Class IV medical device and must be owned and operated by a physician (procedures may be delegated to non - physician employees. An IPL is a Class II device and should be utilized by a physician or an appopriate employee of the physician.

Many states have regulations that can expand or limit the use of these devices.  It must be noted that whenever state and federal laws address the same issue, the stricter of the two will prevail.  Seek th eguidance of a health care lawyer whi is well versed in this issue...admittedly we are rare!

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....

I Have to Get This Off of My Chest....

OK, this really doesn't have anything to do with medical spas or health care...but they are affected by economic irresponsibility...sooooo, I am speaking at a conference in Orlando...for the record, discussing Autologous Adipose Derived Stem Cells vs. Pluripotent stem cells in muskulo-skeletal deficiencies....you asked!

Anyway, while minding my own business in The Disney Dolphin Hotel, a GROSSLY overrated resort, I find myself watching the news... A story comes on about a state senator, otherwise now known as the colossal jackass of politics. Aforementioned colossal jackass of politics proposes legislation that enables ILLEGAL immigrants to receive a college education in Florida under the in-state tuition program.  His rationale??  THIS IS A QUOTE, "we provided them a free education from K-12, so why not college too"?? WHAAAAAT???

So let me see if I have this straight, an illegal immigrant can pay $10,000 per year to attend college in Florida, but a young man or young lady from Georgia would pay $28,000??

Want more?? I did some research...it costs about $25,000 for each student to attend a Florida university.  So, TAXPAYERS will subsidize $15,000 per ILLEGAL IMMIGRANT to attend a university.

Want STILL more?? The illegals earned the money to pay the $10,000 ILLEGALLY and did not pay taxes on it!!!!!!! AND they qualify for financial aid!!!!!!!!!!!!!

WHERE DOES IT END???  And there are some of you that believe that the government can fix real estate, banking, and the auto industry???...they couldn't fix a flat............



The collossal jackass of politics has a name...other than mud....it is Senator Siplan

Update from the 19th Annual World Congress on Anti-Aging and Aesthetic Medicine

Here is an update from the 19th Annual World Conference on Anti Aging and Aesthetic Medicine in Orlando. There is deservedly a lot of talk about two emerging trends..stem cell applications and hormone therapy and conditions.  There is no question that stem cells are the future of medicine and will provide tremendous benefit in out lifetimes.  Stem cells currently have over 220 applications in the human genome and additional applications in the veterinary world. Science is evolving rapidly and new treatments are already being offered and many more in the not to distant future.


We are also learning more and more about the endocrine system and the inter-relationship of hormones.  We are also learning more about the problems that hormonal imbalance can cause. This is a complicated field and there is a lot more to learn.


The challenge for medical providers will be to separate false claims from reality in these two fields.  I have heard some supportable claims at the conference as well as other claims that are....for lack of a better term....NOT supportable by the science!!!

Are Laser Hair Removal Centers Medical Practices???

There have been waves of laser hair removal centers since the first FDA cleared laser was introduced for permanent reduction of hair (1995).  Centers open and close with regularity. It is difficult to maintain a profitable business if it is solely a laser hair removal business.

Eventually, those that open the laser hair removal centers realize this and expand their product and service. Frequently, this is not legally supportable.

The long and short of the situation is that hair removal is not considered to be the practice of medicine.  There are dozens of therapies to remove hair dating back to the ancient Egyptians. Sugaring, waxing, electrolysis, needle free electrolysis, chemical de-epilation are all effective but none are permanent.  The only permanent treatment is laser.

Their are several types of laser for hair removal and a center should have at least three in order to treat the most patients in the most effective way.  This is because of different skin type (color), different hair color and the location of the body.  So, it is not as easy as leasing a laser and opening a location.

Even though laser hair removal is not a medical procedure, the devices are MEDICAL devices. It is unlawful for non-physicians to own or operate the lasers because they are medical devices.  you would never know this if you attend a spa expo and see the laser companies falling over themselves to sell a laser to a non-physician. As I have been known to say, any laser company would sell a laser to my dog Stoli if he could pony up the money!! The laser companies invariably claim to have a letter from a "guy" that indicates that it is acceptable to sell a medical device to a non-physician.

there are some light based devices that are a lower class of ,medical device that can be utilized and owned by non-physicians. These are non effective and low power.

Non physicians can own and operate laser hair removal centers, but care must be made in the formation and implementation of the business plan. As with everything, there is a right way and a wrong way...but the penalties for doing it the wrong way can lead to substantial fines and penalties and loss of professional license (cosmetologist, nursing etc).

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.

Independent Contractor Agreements in Medical Spas

The initial review of ICAs in medicine and medical spas focuses on the Internal Revenue Service (IRS) guidelines. In recent years, the IRS has taken a stronger position in determining that many agreements do not qualify as an ICA. The ramifications of an agreement being disqualified as an ICA are severe. The hiring entity will be required to pay significant payroll taxes and the contractor will lose many deductions that would have been allowed in an ICA. The IRS is thereby incentivized to disallow an independent contractor status.  Blatant abuse of the IRS guidelines may result in additional civil and criminal penalties.

The central element is the amount of “control” that the entity has over the “hired” medical personnel (contractor).  In medicine this is challenging since most medical facilities and practices have procedures, protocols and policies that need to be consistently followed by all medical personnel. This assures continuity of care for patients. It also creates a nightmare in drafting an ICA that does not appear to have too much control over the contractor. It does not help that contractors need to have set schedules for patient scheduling and proper coverage of office hours. On-call provisions have also proven problematic in drafting an ICA. As you can see, it will take more than calling an agreement an “ICA” for it to be considered as such.

Elements of “control” would be the manner in which the services are performed, the hours of work, uniforms, materials being utilized etc. So for example, if a practice mandates that a medical provider utilize Juvéderm as a filler of choice, this would be one indication that the relationship is one of employment as it illustrates “control” by the practice over the medical provider. Another example of “control” would be if a hiring practice delegates any managerial or personnel supervision upon the contracted medical provider.

Medical benefits, pension, regular bonuses, medical liability insurance and paid Continuing Medical Education (CME) are all additional elements or variables that might lead someone to conclude that there is an employment relationship versus one of independent contractor.

 Medical liability insurance is a particularly tricky area since the practice will typically receive a substantial group discount based upon claims history and number of providers.   However, it would be another indication that there is an employment situation if the practice provided coverage for the contractor even if the contractor were to reimburse the practice and functionally pay the premium. Additionally, an insurer may deny coverage for an incident occurring during the care provided by an independent contractor. Never, indicate to an insurer that an independent contractor is an employee.  A sound practice is to send them a copy of all employment and independent contractor agreements as part of the renewal process. The independent contractor should be required to provide his or her own professional negligence policy and be certain that the hiring practice is included as an additional loss payee/insured. This policy will be more costly than it would be if provided for and by the practice, but this is the more prudent approach.  Naturally, it may be necessary to “gross up” the contractor for the cost of the policy. However, I would not recommend mentioning this in the ICA as it may appear that you are mutually attempting to avert the guidelines for an independent contractor.  The better approach would be to determine the cost of the coverage and include it in the base compensation and acknowledge in the ICA that the contractor is required to obtain his or her professional negligence policy, pay for it and include the practice and hiring and/or supervising physician as additional loss payees/insureds.

In the event that a prospective contractor indicates that he or she cannot obtain professional negligence insurance, consider this one of those “red flags” that you should learn to recognize.  Several years ago, there was tremendous difficulty obtaining professional medical liability insurance particularly in certain specialties (OB/GYN for example). However, today, there is little difficulty unless a contractor has a significant loss history.

Another prudent approach is to indicate in the agreement that the medical practice has policies, procedures and protocols that must be followed for best patient care. This is particularly important in the medical spa arena. The ICA should also include an acknowledgment that the practice has certain hours that it is open for patient care and that medical providers are required to perform services during these hours. This will enable the agreement to provide legitimate business and medical reasons for what would otherwise appear to be “control”.

In most employment situations, the IRS has between 17 and 24 elements (depending upon the industry) that it will consider in determining whether an employment scenario is an independent contractor one.  Many areas of business now have their own variables that the IRS employees within that industry. Real estate and many sales positions have clear variables that would be addressed in an ICA. There are no specific variables yet for medical agreements.

The IRS also looks at the type and nature of the agreement to aid in the determination of whether an arrangement qualifies as an independent contractor relationship. A practical example can give some guidance.  In medicine, a physician employed as an independent contractor by a medical practice to perform cosmetic procedures while maintaining his or her own independent office would clearly be appropriate for an ICA. However, a physician employing medical personnel for his or her own practice to perform cosmetic procedures under an ICA may be subject to review.  The reason is that this latter scenario is one in which the medical personnel performing the cosmetic procedures would typically and historically be an employee. There is a higher degree of control.

Independent Contractor Agreements are very useful in medicine today. In situations in which physicians are either hiring or being hired by a practice, care must be utilized to limit the amount of “control” in which the hiring practice is exerting on the proposed contractor. Careful attention must also be given to the historical nature of a proposed relationship. If it is typically and historically one of employer/employee then additional care must be provided on the ICA to avoid an unfavorable determination on the status of the relationship.

Independent Contractor Agreements are particularly troublesome in situations in which a physician, medical practice or non-medical business entity is “hiring” a medical provider to perform additional services within a practice or even more problematically, another business entity in which the “hiring” physician is supervising such medical personnel. There is an inherent appearance that the hiring entity is exercising control over the contractor and the actual type and nature of agreement is more often than not legally unsupportable.