Saturday, April 30, 2011

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!!

Sunday, April 24, 2011

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

Monday, April 18, 2011

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!

Wednesday, April 13, 2011

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....

Friday, April 8, 2011

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 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 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 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!!!

Thursday, April 7, 2011

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).

Tuesday, April 5, 2011

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.

Sunday, April 3, 2011

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 JuvĂ©derm 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.

Friday, April 1, 2011

Non Corporate Practice of Medicine

I received a call today from a client. She received medical treatments in a medical spa in Southern California.  The provider was an RN who owns the medical spa. I have previously advised the client that the medical spa is not operating legally since it is owned by a non physician.  There was a complication and predictably, there is no physician on site or otherwise available.

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.  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.

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.

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.