Kansas State Board of Healing Arts outlaws Lipodissolve

Kansas State Board of Healing Arts outlaws Lipodissolve except in drug trials

By JULIUS A. KARASH - The Kansas City Star Story

 
In a first for the nation, the Kansas State Board of Healing Arts on Saturday greatly restricted the use of Lipodissolve, the controversial fat-dissolving injection.

The board said patients may not receive Lipodissolve unless it is authorized by a physician as part of an investigational drug trial.

“We have to protect the public from the potentially disastrous effects of unproven drugs,” said Mark Stafford, the board’s general counsel, who noted that Lipodissolve is not approved for treating fat by the Food and Drug Administration.

The Kansas restrictions are expected to take effect in mid-to-late September, Stafford said. The board’s unanimous action covers the most common form of Lipodissolve, consisting of phosphatidylcholine and sodium deoxycholate.

The action drew criticism from Matt Taranto, owner of Leawood-based Aesthetic Consulting Group, which manages AesthetiCare Medi-Spa & Lipo Dissolve Center in Leawood.

Taranto said in a phone interview that 10,000 to 50,000 such treatments are administered every month to patients throughout the United States.

“I have yet to hear of a serious reaction or side effect from Lipodissolve,” Taranto said. “It’s an effective way to address localized deposits of fat. The majority of people who have it are happy.”

But Stafford said the board has received at least half a dozen complaints about facilities that give the injections. He said the complaints, which are under investigation, involve problems with business practices and patients suffering side effects such as nodules, infections and nausea.

Lipodissolve is a trademark name. The injections are not designed to treat obesity, but rather to flush out fatty deposits from various parts of the body when patients can’t get rid of them through diet and exercise.

In May, the American Society for Aesthetic Plastic Surgery warned against the use of Lipodissolve and similar treatments. “We do not have definitive information on injection fat loss treatments,” Foad Nahai, president of the society, said in a May 14 statement. “The bottom line for patients is this: Don’t allow yourself to be injected with an unknown and untested substance.”

A placebo-controlled study of Lipodissolve is being sponsored by the Aesthetic Surgery Education and Research Foundation. The study, which will be conducted under FDA supervision, will follow 20 patients for 46 weeks to evaluate the efficacy of the procedure and collect data on reactions and complications.

It is not clear how many Kansas businesses will be impacted by the new restrictions and to what degree. Stafford said the board did not have firm numbers on Kansans who have received the injections or the number of Kansas facilities that administer Lipodissolve.

However, Stafford said the Kansas City area has had one of the heavier concentrations of Lipodissolve clinics, and the board has been aware of perhaps a dozen such facilities on the Kansas side of the metropolitan area recently.

Taranto estimated that Lipodissolve is dispensed by about 20 facilities in the Kansas City area on both sides of the state line.

The Kansas board in April passed a temporary regulation that required a physician to perform a physical exam, record the patient’s medical history and write a prescription before a patient was injected with Lipodissolve.

The board held a public hearing on Lipodissolve last month.

“Other states have been watching to see what we’re doing, and some are contemplating taking action,” Stafford said.

Mark Tucker, president of the Missouri State Board of Registration for the Healing Arts, has said that Missouri might consider stricter regulation of Lipodissolve if necessary.

Hat tip to Ron for sending this to me. 

Can an RN open a medical spa?

Here's a question I received asking if RN's can open medical spas in California.:

"I would like to initially thank you for this informative website you have created; it has helped answer many of my questions.  However, there is one point that remains a little confusing to me, and I was hoping you might be able to clarify it.  I recently went to a famous med spa in Sherman Oaks, California and asked the receptionist who it was that was administering the botox, fillers, laser, etc.  She stated that "excellent RN's"  In addition, they stated that there is an MD within the spa.  

After reading your website, it is evident that an MD supervisor is necessary within a med spa.  

My question to you is can an RN open a med spa business under the supervision of an MD in the state of California?  If so, where would you recommend we begin with the process.  It seems like your site does not approve of consultants of franchises, so what would you recommend for beginners?  Thank you for your time.
Sincerely, C.S."

Here's the short answer: No. 

A medical spa is a medical practice and operates under the same rules. So, RN's are prohibited from practicing medicine by themselves. Your question seems to ask if you as an RN could 'own' the medspa and employ a physician to 'oversee' you. Again the answer is no. Read the medspa legal forums on this site and the medspa legal category.

RN's are often used by physicians as mid-level providers and my guess is that was what was going on at the clinic you went to. But the rules and scope of practice are exactly the same as any other clinic. 

You may certainly be involved and there are ways that 'corporate entities' can align, but you should contact both the state, and a lawyer to make sure you're not violating any state regulations or licensing.

If anyone has other input you're welcome to add it. 

Florida Chiropractor offering IPL.

I was having a discussion with one of my consulting clients today and he dropped this nugget on me.

There's a chiropractor in Florida who is telling other chiropractors that IPL is within their scope of practice. In fact, he's training other chiropractors and selling them equipment. Here's his site: BioDerm Medical Incorporated .

You'll notice on the about page that he's got an MD and is, "licensed to practice Chiropractic Medicine in FL and KY.  He is licensed to practice Oriental Medicine and Acupuncture in WV, and is registered to practice Medicine in Montserrat."

That Monserrat medical 'registration' seems like it may come in handy.

According to this chiropractor:

• IPL is within the scope of practice of DC's since they can use light based therapy's.
•  He was hauled in before the Chiropractic Board of Florida and successfully defended himself by showing that: Although the state of FL regulates IPL as class 4... it's really class 2 and he proved it. The state dropped the entire investigation.
  
• Any other chiropractor can do the same thing.

Since the recent changes in Florida prohibiting non plastic surgeons and dermatologists from overseeing second clinics. This seems odd to me.

Medspa Legal: A dermatologist weighs in on medical directors in spas.

 Dr. Ly from Aloha Dermatology & Laser Center posted this on Medical Directors in Medspas.

"...the medical spa industry often used the term “Medical Director” to lead consumers to believe that a non-physician owned (medspa) is employing a physician to perform medical services in the spa. As stated above. A non-physician owned spa cannot provide aesthetic medical procedures to the public nor can it employ a physician as practitioner. Thus, the use of the term “Medical Director” by a non physician-owned spa to mean a doctor who performs aesthetic medical services on behalf of the spa would be a fraudulent business practice. Only a physician-owned spa can legitimately have a Medical Director.

Consumers need to be aware that a physician who operates a private physician’s office within a non-physician owned spa must ensure that all advertising and marketing materials used by the spa properly disclose the physician’s relationship with the spa.

Many non-physician spa owners believe they can employ a physician to be their “Medical Director” and perform aesthetic medical procedures within their spa. This is incorrect, and any physician who accepts employment by a non-physician spa owner with the intent of performing aesthetic medical procedures as the spa’s medical director is subject to disciplinary action and increased liability."

I wonder what American Laser Centers, Dermacare, Sona, Solana and the rest of the medical spa franchises would say to that.

Dr Ly is right of course in the strictest sense as I've posted before: What's legal in a medical spa? l Why physicians & medical spas are a legal nightmare. l Sona Medspas: Legal structure & revenue sharing. l Medspa Legal: Can a non-physician employ a physician.

However, there are ways in which physicians can deliver services at locations or businesses they don't actually own. (Any hospital is and example of that.)  

Electrologists in Florida can perform laser hair removal?

This kind of underground 'you can do this' stuff pops up regularly regarding laser hair removal. Who can do it? Who can't?

 
Here's a comment that was made that, if you just read it, would lead you to believe that Electrologists in Florida can perform laser hair removal.

Here's the comment and the note I left on it.

From adrisen: "In the State of Florida one needs to be an Electrologist before they can do laser hair removal.  I contacted them becasue I am moving here in 15 months. Thank you for the information on the Harmoney.  There is another unit that I am looking into and might ask about.  Thanks everyone."

(NOTE: I've decided to leave this comment up although it's incorrect. In every state in the US, laser hair removal is considered and regulated as a medical treatment and must be performed under medical supervision at the least. Electrologists on their own, may not perform laser hair removal any more than Jane Doe on the street. There are no exceptions and every state is the same with this basic premise.)

Now if you're an electrologist, don't get out your powered knitting needle and come looking for me. Call us crazy but the US regulates medical treatments.

Medical Spa Legal Discussion Thread

Medspa Legal Category: Blog posts dealing with the legal issues of medical spas.

Non Compete Agreements: Keeping your Medspa staff from killing you.

Are Non compete Agreements Valid?

It's common for physicians to ask about how to prevent nurses, estheticians, or even other physicians from leaving to work for a competitor?

Many physicians ask their staff to enter into broad non compete agreements or employment contracts with non compete provisions to prohibit departing employees from working for a competitor or from using information they acquired while working for you. Or perhaps you just want to specify how soon an employee can begin working in a similar business.

There are problems with many non compete agreements valid and if overly broad they're not legally enforceable?

As a general rule, non compete agreements--often referred to as agreements or covenants not to compete--aren't valid or are not readily enforcible. In most states, there's a longstanding, strong public policy against such agreements since they're often so one-sided and impinge upon an individuals ability to make a living which is frowned upon by legislatures. The rationale for this policy is to ensure that employees have the right to pursue any lawful employment of their choice. (The California Legislature has enacted a law that declares void every contract that prevents someone from engaging in a lawful profession, trade or business of any kind.) Of course, as with most laws, there are exceptions provided in the law and created by the courts. In most states, the courts have carved out an exception to the general rule that covenants not to compete are void. They're typically permitted when deemed necessary to protect valid trade secrets of the employer. When former employees engage in unfair competition through the unauthorized use of trade secrets or confidential information, the courts will generally enforce proper non compete agreements.

A non-compete agreement which prohibits someone from working anywhere is far less likely to be valid than one which prohibits someone from working within 10 miles of the former employer’s business but this will depend on the kind of work. Your medical spa may have an interest in keeping an esthetician you trained from competing across the street, but if the non-compete agreement says nowhere in the state, it becomes less reasonable. If the esthetician can find a job in the state 50 miles away, most of the clients will not travel that distance for the service, but will stay with your medspa. On the other hand, this non-compete could force the esthetician to move to look for work or otherwise to travel hundreds of miles.

A non-compete must also be for a limited and specified time. If the esthetician is gone for a year, the medical spa can expect that the vast majority of the customers will have stayed and the estheticians departure will likely do little harm to the business. Thus, keeping the esthetician out of work for three years does little to help the business, but seriously harms the esthetician .

Depending on the circumstances and the language used, agreements not to compete signed by employees when starting a new job can prevent them from legally using secret formulas, recipes, certain protected customer lists and other trade secrets. Of course, merely labeling information as a trade secret or as confidential doesn't make it so. Disputes as to whether certain information is truly secret or confidential are decided by the courts on a case-by-case basis.

A similar issue arises when an employment agreement attempts to prevent a departing employee from taking other employees with them to a competitor. Such non-interference agreements aim to prohibit employees from soliciting other staff members to leave the employer. It's clearly improper for a departing employee to induce fellow employees to breach their employment contracts. On the other hand, if there's not an employment contract, nothing prohibits employees from deciding to join a colleague at a new employer.

In the end, to be valid a non-compete agreement must be narrowly tailored to meet the needs of the employer which will be balanced against those of the employee. If you are preparing a non-compete agreement, you need an experienced lawyer to draft it in a way that it will not be held invalid. If you are dealing with a non-compete agreement as an employee, there are lots of ways to attack it.

However, there are ways to accomplish what you're trying to do without having to rely on non-compete agreements exclusively. The key is that any agreement must be made by knowledgeable and informed parties and can't limit an individuals ability to make a living. 

When Surface was first formed I had all of our staff sign non-competes since they were constantly being poached by both competitors and schools who wanted to boast that "the instructors worked at Surface". I found that my energies were better spent elsewhere. My staffs will often receive boastful offers from competitors. Interestingly, they're almost never accepted. (The last one was years ago.) Why? I'm transparent with my staff to an extent that they know they can trust me. (Another post on this later.) 

We do prevent our physicians from competing directly with us, but it's not through non-competes.

Of course, as with any legal matter, you are always advised to consult an employment law attorney when considering anything legal. If you do something stupid, it's your fault.

Sorry Cosmetic Doctors & Lawyers.

Customer service vs. CMA (cover my ass) defensive medicine.

Aesthetic MD has commented that saying you're sorry to a patient prevents a large number of problems and can preempt the loss of a patient or possible litigation.

But the majority of doctors have a problem saying 'sorry'.

"Dr. Michael Migliori had the delicate task of telling the woman she needed a third operation. He began with two words that could make a defense attorney's head explode: I'm sorry.

"In this state," Migliori said in a recent interview, "that can be used essentially as an admission of guilt" if a patient files a malpractice suit...

...The surgeon said that he realizes an apology could come back to haunt him but that he considers saying "I'm sorry" essential to preserving the bond of trust between doctor and patient.

Otherwise, "patients think I'm hiding something, I must have done something wrong," he said.

Apology laws vary by state. In Arizona, Connecticut, Idaho, Maine and 11 other states, doctors can safely apologize to or commiserate with patients or their families about an undesirable or unexpected outcome, according to the AMA.

Personally, I think expressing concern and regret for unwanted outcomes is entirely appropriate. 

States taxing plastic surgery & cosmetic medicine.

From the Denver Post: MN to tax plastic surgery

State Rep. Phyllis Kahn is pushing to extend Minnesota's 6.5 percent sales tax to include cosmetic surgery and appearance-enhancing procedures including chemical skin peels, laser hair removal, cosmetic injections and spider vein treatments.

Anybody who has the money for plastic surgery can afford to pay the tax, said Kahn, a Minneapolis Democrat.

"There aren't a lot of homeless people and there aren't a lot of people who don't have enough money for food who are getting optional cosmetic surgery," she said.

New Jersey is the only state that taxes cosmetic surgery, collecting an estimated $11 million this year. Kahn said her proposal would raise about $7 million a year.

Most of that money would come from the bank accounts of hardworking women, said Dr. Richard D'Amico, president-elect of the American Society of Plastic Surgeons. He said 90 percent of plastic surgery patients are female, with annual incomes averaging about $60,000

Physician Oversight: Michael Cohen, Camlaw

Medical Spa legal issues post by Michael H. Cohen, a lawer who deals in this area.

Medical Spa Legal Issues

Laser Therapy Physician supervision requirements can make delivery of medical spa therapies expensive. Some spas opt to have medical directors off-site and on the books in name only, thus providing a panoply of inexpensive therapies through various providers. Is this legal? It depends.

Read the post here.

Inside Sona Medspas Part 6: Medical Directors & Physician Oversight

 Medical Spa MD - Inside Sona Medspas Part 6: Physician Oversight

These posts are written by former Sona Medspa owner Ron Berglund to provide an inside view of the way medical spa franchises recruit, train, and support their owners as well as detailing some of the problems with medspa franchises.

Read Part 1: Why I bought a Sona Franchise l Part 2: Sona Promises l Part 3: The Franchise Pitch l Part 4: Legal Structure & Revenue Sharing l Part 5: Opening a laser clinic

Sona Medspas: Physician Oversight

About medical oversight at Sona?

What did Sona tell us?  Sona gave us some rather generic information about the requirements for a medical director as they were aware of the pertinent statutes and regulations.

Sona's manuals included a generic "Medical Director's Manual" and "Nurse Manual" which covered some of the relevant concerns. Their franchise documents and verbal statements naturally put the burden on each individual franchisee to get legal counsel in their state to cover all the bases, etc. They provided us with a generic "standing orders and protocols" document for the nurse to provide to the treating nurses (or "laser technicians") which provided a good start for most.

I know that in California and a number of other states the standard Sona model did not work and these franchises had to have significantly more creative (and expensive) legal work done to structure the operation properly. In a number of other states the clinics had to be located literally "across the hall" from the medical director- or the clinic had to incur significantly higher expense to have a physician actually "on sight" to comply with that state's laws and medical board regulations. (Read: Can a non-physician employ a physician.)

In Minnesota we employed the standard off-site "medical director" model which required a licensed physicians to "oversee" clinic operations and protocols. (Read: Physician oversight in medical spas l Mid-level providers in medical spas)

Sona was strict about requiring our docs to review and either sign or initial each patient chart and each entry on every treatment log to double check that proper parameters were being used, etc. We also had a decent system set up requiring "adverse event" reports for every "incident" which was also sent to the corporate office each month. Fortunately, we had very few adverse events over the years--partly because the majority of our treating nurses were primarily interested in CYA and not having any of their patients experience "discomfort" or causing any minor burns or blisters. Due to the very conservative teaching and recommended parameters furnished by Sona our BIGGEST problem through the years was with EFFICACY.

The majority of our treated patients still had significant hair remaining after five treatments-- which caused most Sona operations to slowly crumble due to patient dissatisfaction and demands for additional free treatments, etc.

Did your system work for your medical directors?

The main problem encountered by both Minnesota clinics for the first few years of operation was keeping a medical director in place.

 

We went through a succession of medical directors for a variety of reasons-- retirement, relocating, not being comfortable with the procedures or the risk involved (vs the small fee we were willing to pay the medical director which ranged from $1500 to $2000 per month per center).

 

The most outrageous situation was our young dermatologist who was forced to give up her "moonlighting" job due to an edict issued by her boss-- who coincidentally was the head of her department at a major university and also owned a competitive laser center in the same city!.

 

Medical Oversight Problems?

The centers in Minneapolis and St. Paul actually operated without incident for six and four years respectively without incident until a female police officer treated in St. Paul (Woodbury) experienced a minor burn typical of treating skin with a "base tan" with high parameters required for Alexandrite laser hair removal treatments beyond the third or fourth treatment when high parameters are required for efficacy. 

 

Even though I told this woman that our nurse absolutely followed our established laser parameters, etc. she insisted that the nurse had done something wrong so she lodged a formal complaint with the Minnesota Nursing Board. The nursing board did a preliminary investigation and shipped the case to the Minnesota Attorney General's office where it is still under investigation. All this attention caused me to take a close look not just at the Minnesota statutes and regulations covering physicians but also the Nursing Board Act.

 

I was very surprised to see the level of detail required to legally employ nurses to operate lasers in Minnesota. I wrote a separate blog on this topic in another section of the web site where I asked if anyone out there was aware of a college or university that could provide a 30 hour course on the use and operation of lasers required by the nursing board.

 

They also require a very detailed delegation /prescription document from the physician to the nurse similar to what a nurse would need to legally dispense prescribed medications.

 

What questions did the staff have about this?

In order to try to avoid getting my staff riled up and worried about these "legal" issues (and the fact that they may have been guilty of "practicing medicine without a license"), where they were potentially  at risk of losing their nursing licenses, etc., my usual practice was to say as litle about this as possible.

 

My nurses were always well trained (especially after we started doing our own in-house training) and always treated patients cautiously. As we became more experienced we began doing more and more test spots-- even though these were not encouraged by Sona for the 80% of our patients who were Caucasian. 

 

After our business had collapsed financially in early 2006 we actually operated for several months without a medical director because my partner refused to dig deep enough to pay for one and we were primarily treating existing patients by this time.

 

During the late spring of 2006 my experienced nurses started to ask directly who the medical director was and they noticed that nobody was reviewing the charts on a weekly basis as had been done the previous three years. At this point I told them that my personal friend (a dermatologist who had been traveling regularly between Florida and Minnesota the past five years and had served as our director for several months previously) had agreed to act as our medical director for the time being. This was a stretch, of course. It is tough to do things right when you are stone cold broke!

 

Whart were your concerns with the medical aspect of the business? 

Once again-- hind sight is 20/20. But in the aftermath of my Sona experience I am more convinced than ever that MEDSPAs are not the place for entrepreneurs and non-medical businessmen. Most of the "doc in the box" business models have collapsed-- and I believe more will soon follow.

 

I believe the survivors will be the physicians who are actually owning and operating the clinics. This makes sense marketing wise-- as docs can market extensively and much more economically to their existing patient population-- as well as legally. I would venture a guess that a prospect is five times more likely to respond to a direct mail piece or a newsletter that comes from her physician than a mailer from an unknown operation that-- for all she knows --could be operated by any flake out there (maybe even a telephone call center headquartered in Michigan!).

 

Ron Berglund

Medspa Q&A: Legal: Can a non-physician employ a physician?

 This question pops up regularly so I'll bring it over here and answer it.

Question: Is it illegal for a non-physician owned medspa franchisee to employ a medical director? Can a non-physician owned medspa franchisee (physician owned franchisor) legally employ its own medical director? - ELH

ELH, Thanks for the question. Here's the answer. 

Answer: A non-physician can not employ a physician OR own a medical practice that employs a physician OR partner in a medical practice with a physician. Only physicians can employ or partner directly with other physicians.

Most of the generally accepted principals of business do not apply for one simple reason; You, as a non-physician, man not be involved in the practice of medicine in any way. 

Sure, hospitals and HMO's employ physicians but they have lobbyists in Washington, you do not. This is an absolute so I'll state it again, non-physicians can not employ physicians as employees. There are no exceptions (no matter what a medspa franchise might say.) Read the WSJ article on unhappy medspa owners here.

Clarification: That non-physicians can not employ physicians is an absolute rule. However, there are ways in which non-physicians can do business with physicians but they require a careful legal setup that doesn't violate the law.

• Example 1: You have a spa with a visiting physician who comes in and performs Botox and Restylane. You 1099 them at the end of the year as an independent contractor. WRONG: You can not do this as you would be employing a physician.
  
• Example 2: You have a spa and a physician solicits you to allow them to come in and treat your clients. The physician and you plan to split the revenue. WRONG: This would put you in a partnership with the physician as well as potential trouble for splitting fees. Big, big, trouble.

 Additional: In situations where a medical spa is set up incorrectly, the physician will be at risk. Every malpractice policy will be voided if a physician is practicing outside of the law, which this is. A physician who gets in trouble in a situation like this will be completely on her own and my best guess is that the prosecuting party will be happily pointing this out in court... not a good place to be.

The non-physician will be at risk as well. A physician can shut down your business at any time by refusing to extend their oversight to any medical treatments. The state could also be a problem since if it's found that you own a 'medical' business, you'll be shut down by the state tute suite.

You should be very wary about how you state what you own. While I've used examples of what you may not do, I've stayed away purposefully from exactly how you can legally set this up since I don't want to give advice that someone might follow and get themselves in trouble. Consult a lawyer who specializes in this area of medicine.

Wall Stree Journal Article on Medical Spa Franchises: Medspa boom is a bust for some

The following article on problems with medical spa franchises ran in the Wall Stree Journal. It's a telling article that points the finger at the current crop of medical spa franchises. I signed up and read it after Ron posted his comments on being an unhappy Sona owner.

Medspa Boom Has Become a Bust for Some

By RHONDA L. RUNDLE: November 21, 2006

Jeff Nebot thought he had struck gold. Two years after opening a laser hair-removal franchise in St. Louis, annual revenue hit $3 million. And over time, the lavish salon added other cosmetic services as Mr. Nebot joined the rush of entrepreneurs into the emerging business of medical spas. Medspas (also called medispas) offer such medical treatments as Botox injections and laser hair removal in a luxurious environment rather than a doctor's office. The field has been rapidly expanding in recent years as entrepreneurs and doctors alike have sought to profit from the dual quests of many affluent consumers: prettification and pampering. For an increasing number of those who entered the business, the boom is proving a bust.

"Several Sona franchisees, though not Mr. Nebot, are in private arbitration over problems that include misrepresenting a complicated business as a turnkey operation and failing to provide needed support. Sona officials declined to comment.

Several franchisees of Radiance MedSpa Franchise Group PLLC, a franchiser in Scottsdale, Ariz., say the company's financial projections overestimated revenue and underestimated initial start-up costs, including working capital.

The president of Radiance, Charles L. Engelmann, recently said: "There are currently 32 open stores and we will have 47 or 49 open by the end of the year. None of the stores have closed." He also acknowledged that some franchisees are attempting to get their money back.

"I can't be my own medical director any more, which is an added expense I can't afford," says one Florida physician who is not a dermatologist. He says he is "facing personal bankruptcy and trying my best to get out while there is something left for my family" after miscalculating what it would take to market, advertise and build his business. Indeed, many medspa owners are doctors who hope to make easy cash at a time when income is shrinking from their traditional medical practices.

You can read the entire article on the Wall Street Journal site here. It does require a subscription. 

Cosmetic Medicine: The Unhappy Patient

How to ask the patient to stop seeing you.

I shouldn't have even said "unhappy patient." I should have said the forever unsatisfied patient. Thankfully this is a very infrequent situation in our practice, but it happens every once in a while. And it leaves such a mark, that I thought I'd ask how other physicians handle these scenarios in their own practice.

Last year I saw a patient (56 year old woman) and treated her with a little Botox between her brows and some Restylane in her nasolabial folds and the lines above her lip. She came back to see me 2 weeks later and fell into tears in my office. In fact, I was moved to tears since it truly seemed like I had ruined her life (there's where I should have seen the first red flag, but I missed it). She felt like she had all sorts of new wrinkles, her brows had fallen, etc. Unfortunately (and let this be a lesson that some of you might learn from my mistake) I hadn't taken "before" photos of her. And that was unusual since I really do take pictures of almost everything I do. Especially the first time I treat a patient. And now I absolutely do! Anyway, I couldn't see any "lowering of her lids" from the Botox. In fact, the Botox did exactly what I had expected and had informed her beforehand that it would do. I assumed she just didn't like the effect. But in terms of the Restylane, she saw all sorts of new lumps, new horizontal wrinkles and changes to her original appearance.  In her defense, I did seem some minor areas I could fix and so I did so at no charge to her. And this time I took photos. I also added some Botox to her lateral brows hoping we would see a little lift there to alleviate what she saw as "drooping."  But there was no ptosis or any of the potential complications that could occur from Botox.

She returned to see me again in another two weeks and again was still unhappy. I had ruined her "girl's weekend" in Vegas because she couldn't leave her hotel room looking so "horrible." Again more tears. But I managed to take some more photos and compare them to the ones we had taken on the last visit. Her brows were elevated a bit and her lip lines and nasolabial folds looked great. We even zoomed in to take the closest look possible. But she was not swayed.  She was convinced she still looked horrendous and that I was to blame. So now I'm starting to notice a little bit of the flag. But it's still in my peripheral vision  I really listen and try my best to understand where she's coming from, but honestly I think she looks pretty good. Course it doesn't matter what I think, I still have a dissatisfied patient sitting in front of me. But I didn't think adding any more filler or Botox was going to improve the situation. So I ask her what she thinks can be done. And she comes right back, in a very matter of fact tone, and says that she feels the most appropriate next step would be for me to perform a thread lift on her at no charge. So right about now the red flag is waving frantically in front of my face....hopefully hiding the look of shock.  My mind is filling with all sorts of questions...like why would she want something more invasive, more long term? And if I'm the one who has ruined her life, why does she want me to do another procedure on her? 

Right about then I realized that she wanted more procedures done, but she just didn't want to have to pay for them. So in the nicest way I knew how, I simply said that I didn't think that I was going to be able to satisfy her needs.  I was concerned that there was little, including a thread lift, that I thought I could do to meet her expectations. And I wasn't sure whether she had unrealistic expectations or if I had promised the sun, stars, and the moon. But somewhere between what she wanted and what I could deliver, there was a great divide. But knowing that all our office offers are minimally invasive or noninvasive procedures, I routinely spend a great deal of time in the initial consultation. If a patient comes in to see me and has complaints that cannot be adequately treated with the procedures I offer, then I usually refer them to one of the plastic surgeons in the area. I try hard to communicate the strengths and weaknesses of what I can do in my office verses what a surgeon can do in the OR.  So I doubt I had given her the impression that a little Botox and filler were going to make her look like she was 22 again.

And I certainly didn't think it was going to be a good idea for me to be performing any more procedures on her given she already didn't like what I had done. Did I mention she had already spoken to her attorney? I think I forgot to tell you that part of the visit. At the end of my previous visit with her, she told me that her attorney had advised her to stop payment on the check that she had originally written for her initial services. I wasn't sure if that was even legal or not, but needless to say, that put a damper on our relationship. And then when I said I didn't feel it was in either of our best interests to do the thread lift, her tearful eyes quickly changed to scowling ones and she let me have it. I asked my office manager to step into the office with me since I wanted somebody else to witness the exchange. But now she turned from a weepy patient to an angry woman who was yelling and screaming at me.  Since it quickly became apparent that we could no longer communicate in a constructive manner, I let my office manager (who is extremely proficient in all situations) try to diffuse the tension. 

Cosmetic medicine is still medicine and needs to adhere to the regulations governing any practice. But are the terms somewhat different when it comes to patient "abandonment" and how to notify a patient that you no longer wish to be their provider? What happens when a patient wants you to do something that you don't feel comfortable doing? What if it gets ugly? Please share your stories or thoughts on these situations.

To learn more about how to end the Doctor-Patient relationship and the legal aspects or ethics involved, click here

Physician Oversight & Scope Of Practice: What's legal in a medical spa?

Physician oversight & scope of practice in medspas.

We receive an ever growing number of questions about physician oversight, scope of practice, and other legal issues surrounding medical spas. What oversight is required? What can I do? What can't I do? Here's our opinion (ie. not a legal one.)

The quick growth of medical spas has led to something of a Wild West mentality. Many spa owners and even some physicians are trying to jump into this market. Unfortunately, this has landed a number of medical spas in hot water. Very hot. Medical spa professionals and many physicians don't understand the legal ramifications of what they're doing. What's legal? What's not?

Here's a sample: "Hello, I am an esthetician currently working in a day spa. My boss has decided to buy and train another esthetician and myself on the Thermage system. Since we are a medical spa, there is no practicing physician on the premises. My question to you is; how legal will our Thermage treatments be without an overseeing physician? By performing these treatments, will my license be on the line?"

Short Answer: Performing Thermage under the above circumstances is practicing medicine without a license.

Longer Answer: There are a couple of problems the question alludes to. First, the 'boss' appears to be someone other than a physician. Non-physicians can not purchase medical devices restricted by the FDA to physicians only. Second, if patients would be treated medically without an examination or being seen by a physician that is absolutely illegal. Third, 'no physician on the premises' is a big red flag. Doctors can not extend their licence to Thermage any more than they can extend it to surgery. It doesn't matter that a physician is directing that the treatment be performed or that your boss thinks it's safe. Fourth, Yes, your licence is at risk. Anyone performing medical treatments without adequate oversight is going to be between a rock and a hard place if anything happens. Thermage (and every other medical treatment) have potentially harmful side effects. Don't think for a moment that you, the doctor, or the business are protected by a physicians medical malpractice if a treatment is performed illegally. (Always check with an experienced lawyer.)

Physician Oversight

Physicians are responsible for every treatment performed under their medical license. If it's a medical treatment, the physician is responsible and liable for the performance of that treatment. The state medical board has jurisdiction as to scope of practice and physicians can't extend the scope of their medical license.

Aestheticians and medical spa technicians performing 'medical treatments' are doing so under the license of a doctor. If the doctor can't extend his license to that particular treatment, it's not covered by his licence and is being performed illegally. Anyone, including the physician, involved with treating patients without legal medical supervision is asking for trouble.

Post your question as a comment on this post and we'll add the answers here.

Question: I really appreciated this article. But I'm wondering, what are the issues involving an registered nurse or nurse practicioner, both of which are entering the esthetics industry? Does a spa offering Botox with a np need a doctor on site? What if that np is working in a state in which np's can operate as an individual business? What options does a spa have with nurses as opposed to a doctor or esthetician?   Spalady

Answer: Nurse Practitioners (NP's) and Physicians Assistants (PA's) in some states have the ability to operate outside of the direct supervision of physicians.

Both must have an arrangement with a physician to supervise them and enter into an agreement with their supervising physician that gives access to the doc. PA's are limited in that they can not open up a business by themselves and have to report more directly. (Which is one reason PA's are more attractive to physicians since they can't just open up in competition with you.)

Registered Nurses (RN's) do not have the ability to operate outside of the direct supervision of a physician in the same way as NP's.

It breaks down as this: NP's and PA's may have the ability to provide medical oversight if a physician is not physically on site, RN's do not. You should always, always, always, have your lawyer check with the state since they're the ones who will decide.

Good advice from a lawyer I know is this: write to the state detailing exactly what you are doing. Do not try to sugar coat it at all. Ask for a written reply from the state saying that they have no problem with you. Keep this as documentation if something goes amiss. That way you have a state regulatory body saying that you were performing within the scope of practice. Excellent advice.

Read the comments since there is some elaboration on scope of practice.  

Follow the medical spa money trail in Florida. A comment worth repeating.

An excellent comment from Denise Curtis (a PA) from a discussion thread on the new regulation governing medical spas in Florida.

Dear MDMan,

All PA's are required to be registered with their state medical boards and by law are required to have continuing education. In NC, the requirements are EXACTLY the same for PA's and MD's, meaning we have to have 100 hours of Category I CME's every 2 years. Furthermore, PA's must pass a national certification exam before practicing and must sit for this exam every 6 years to maintain their certification. Physician Assistant programs now require a BS degree prior to entering PA school and then grant a Masters upon completion. Unlike nurse practitioners, PA's have always maintained their dependence uppon physicians. However, this does not mean that PA's cannot practice independently of their supervising physician.

It is sad that there are many places in this country where a PA is only health care provider willing to work for very low wages to provide basic health care the those rural areas. In those situations, the PA may be the only provider for hundreds of miles. With the passing of these bills not allowing PA's to see patients independently in medical spa settings are they then going to require an MD to be present in all of those health department and rural settings? Think about this for a minute. Basically, they are saying that a PA is not qualified to do laser hair removal but that a PA can provide health care in lower socioeconomic settings. In some of these settings, the PA's run codes, put in A lines, triage critically ill patients, only because there is a lack of MD,s willing to work in those settings.

Do you think this country can afford to put such restrictions on health care? Furthermore, do you think that laser hair removal is more dangerous than running a code?

It is always about the money and control!!!!!

Denise Curtis