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The FDA and Medical Aesthetics: 2017 Regulatory Roundup

Posted By Administration, Wednesday, January 3, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

In recent months, the U.S. Food and Drug Administration (FDA) has begun to focus in on the medical aesthetic industry with a number of rulings on products and procedures, as well as some enforcement efforts. Here’s a quick rundown of the stories from just the past few months:

On September 15, the FDA issued a guidance document that suggested that in the near future, it will begin regulating the use of in-home microneedling devices to prevent injury to consumers.

In October, the agency raided a number of pharmacies in Florida that helped customers order relatively inexpensive prescription drugs from Canada and overseas. This may represent a reversal of a long-standing “non-enforcement” policy regarding this particular form of parallel importation. 

On November 14, the FDA warned consumers and health care practitioners about serious injuries and disfigurement that can result from the illegal use of injectable silicone or fake dermal fillers.

Also in November, the agency issued a consumer update expressing concern about stem cell treatments that are potentially harmful to patients. In it, the FDA outlines its stance on stem cell treatments and offers advice to those seeking them out.

On December 11, the FDA issued three policy papers designed to clarify its approach to the evolving oversight of digital health tools, including fitness trackers and patient support software. This is an advancement of the agency’s Digital Health Action Plan, which was introduced in the summer.

The FDA has also issued approvals for a number of products used medical esthetic treatments.

Merz North America’s Describe PFD patch was approved for use with all tattoo removal lasers; this patch is positioned over tattoos prior to laser removal, enabling multiple rapid laser passes in each treatment session. 

Aclaris Therapeutics’ Eskata (hydrogen peroxide) topical solution has been approved for the treatment of raised seborrheic keratoses

And perhaps most significantly for the medical esthetic industry, Allergan’s Botox neurotoxin has been approved for the temporary treatment of forehead lines.

Given the FDA’s recent increase in activity that could affect med spas, we feel it is important to hear directly from the agency regarding its enforcement efforts. To that end, we have booked Dr. Sangeeta Chatterjee, branch chief in the division of supply chain integrity, to speak on February 11, 2018, at The Medical Spa Show, which will take place at Aria Resort and Casino in Las Vegas. Dr. Chatterjee’s presentation will cover:

Threats to the U.S. drug supply chain;

Public health risks and potential legal consequences associated with purchasing unapproved prescriptions drugs from unlicensed sources;

Safe purchasing practices to ensure the drugs administered to patients are safe, effective, and FDA-approved; and

How to recognize drugs that may be counterfeit or not approved by FDA.

Registration for the show is currently open; click here to learn about the various registration options for the show, see the full schedule, and find out how to reserve a room in AmSpa’s room block at the Aria. Sign up for AmSpa’s email newsletter to continue to get the latest news on medical aesthetic regulations directly to your inbox

Tags:  FDA  Med Spa Law 

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Medical Spa & Aesthetic Laws and Regulations Matter More Than Ever

Posted By Administration, Wednesday, December 27, 2017


By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)


In November 2017, Surfside, Florida, police arrested Alicia Giser, an employee at Lemel Medical Spa, who was accused of practicing medicine without a license. Working off a tip from the Florida Department of Health, Surfside and Miami-Dade County police conducted a sting operation in which Giser represented herself as a doctor and agreed to administer a Juvederm treatment to an undercover officer. Giser has claimed that she is a doctor in her native Argentina, but Florida officials assert that she is not licensed to practice medicine in the state of Florida.


Giser’s case is an example of the kind of thing that’s existed in the medical aesthetic industry for many years, but which regulatory agencies have typically been unable or unwilling to police. That is no longer the case, and it could signal a major change in the status quo for the future.


This time of year, it’s fairly common for people to ask me what trends I think will help shape the medical aesthetic industry in the coming year and, for the past few years, I’ve told them that a rise in regulatory enforcement could play a major role in the industry’s evolution. I sense that enforcement efforts are increasing throughout the nation, so if your medical spa or medical aesthetic facility is not thoroughly compliant, you should do whatever you can to correct that as soon as possible. (AmSpa members have access to their state’s summary of laws governing aesthetics, and a complimentary introductory compliance call with an aesthetic healthcare attorney from the law firm of ByrdAdatto.)


In Florida, for example, there have been a number of high-profile regulatory violations—including the one in Surfside in the recent past, as well as more of the “mundane” cases where people get in trouble for offering procedures they are not qualified to perform—than I can remember seeing before. New York has also been cracking down on medical spas that are not compliant. The lens is focusing ever more closely on this industry, which is not surprising, given the explosive growth it has experienced in recent years.


Regulatory bodies in states such as Texas, Virginia, New York, New Jersey, Illinois, and Arizona are actively creating, amending and clarifying legislation in order to better define what is and what is not allowed in a medical setting. This was recently true for the state of Illinois, which amended its nurse practice act to allow nurse practitioners to achieve full practice authority, giving medical spas in that state a better idea of how to utilize their employees. Also, the Georgia Composite Medical Board recently created a state licensure procedure for laser technicians. 


As an industry we need to be compliant, we need to self-regulate, and we need to get our own house in order so that we appear credible and legitimate to regulatory agencies, other powers that be, and consumers. The violations that have been seen in Florida, Texas, New York and other states in recent months are the start of a wave of enforcement that I expect will shape the industry in the coming years.


Remember, ignorance is not an excuse, and it is up to you to make sure that your medical spa meets your state’s standards.


Sign up for AmSpa’s email list to stay on top of changing medical aesthetic regulations, and for tips on how to get the most out of your aesthetic practice.

Tags:  Med Spa Law 

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Legally Compliant Medical Spa Events to Keep the Holidays Happy

Posted By Administration, Thursday, December 14, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Many medical spas and medical aesthetic facilities thank their loyal customers and VIPs with events or parties during the holiday season, where people can undergo treatments while enjoying refreshments with friends and employees. However, despite the frivolity, medical spa owners and operators need to take care to observe all the rules and regulations that they would in the normal course of business. In fact, in a party setting, this might prove to be something of a challenge.

Principle among these concerns is patient privacy. In a party setting, it might seem like no big deal for operators and attendees to take pictures and post them on social media; in fact, it’s the sort of behavior that a traditional retail outlet might encourage, since it shows customers having fun in an exciting setting. However, if photos of a party your medical spa is hosting are posted without a patient’s consent, it is a violation of HIPAA and likely other state regulations related to patient privacy, since you are tacitly admitting that these are your patients. Make sure that anyone appearing in photos you want to post from the party has consented to you using his or her likeness in this fashion; this typically can be accomplished with a disclaimer on the invite, although you should check with your healthcare attorney to make sure that this covers you completely.

Also, regardless of where the party takes place—it’s common for patients to host Botox parties, for example—you must observe the same procedures and protocols that you would in the course of your everyday business. In most states, the law requires that a physician must conduct a face-to-face consultation with each patient who seeks to undergo a medical procedure, and regardless of whether you’re administering these treatments at a party or during normal business hours, they are medical in nature and subject to the rules and regulations that govern medical procedures in your state. (AmSpa members can check the legal summary of medical aesthetic laws in their state.) So by the letter of the law, a physician or licensed practitioner (such as a nurse practitioner or physician assistant) must take a history, conduct a physical and administer an examination to each patient.

After a successful consultation, the patient’s treatment can commence, and while that treatment does not necessarily need to be conducted by a physician or licensed professional, you must make sure that proper supervision is provided. Provided the procedure falls within their scopes of practice, non-licensed professionals—such as laser technicians or nurses—may perform the actual treatments in lieu of a physician. However, a licensed professional must be available during the treatment, should the non-licensed professional require his or her assistance.

It is a good idea to make sure that a physician or another licensed professional is always on-site while medical procedures are being performed. Most medical spa treatments have very little risk of complications or negative outcomes, but if one should occur at one of these parties, the presence of a licensed professional will help protect the business against charges of impropriety.

This might seem like a lot of trouble to go to for a party, but the last thing in the world you want is for your state board of health to leave a citation in your stocking. Make sure all your legal bases are covered, and have a happy holiday season!

Tags:  HIPAA  Med Spa Events  Med Spa Law 

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‘Tis the Season: Gift cards for Medical Spas

Posted By Administration, Tuesday, December 5, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Medical spas typically see an uptick in sales of gift cards during the holiday season. And although selling or giving away gift cards may seem like simple transactions, the fact that medical spas are medical institutions does complicate matters a bit from a legal standpoint. Following are a few things about distributing gift cards that medical spa owners and operators should keep in mind.

First and most importantly, there are federal regulations that govern gift cards. The Credit Card Accountability Responsibility and Disclosure Act of 2009 includes provisions that protect consumers from fraudulent and predatory practices by those who sell gift cards. According to the Federal Trade Commission (FTC) consumer information website:

 "Money on a gift card cannot expire for at least five years from the date the card was purchased, or from the last date any additional money was loaded onto the card. If the expiration date listed on the card is earlier than these dates, the money can be transferred to a replacement card at no cost."
 "Inactivity fees can be charged only after a card hasn't been used for at least one year, and you can be charged only once per month. But you may be charged a fee to buy the card or to replace a lost or stolen card."
 "The expiration date of a card must be clearly disclosed on the card, and fees must be clearly disclosed on the card or its packaging."

If your gift cards do not meet these standards, you certainly should do what you can to amend them. The FTC responds to consumer complaints regarding gift cards from retailers, and you don’t want to run afoul of it.

Also, gift cards for medical spas fall into a bit of a strange grey area due to the corporate practice of medicine, a doctrine observed by many states that dictates that only a physician or physician-owned corporation can receive payment for medical services. Since many of the treatments offered at medical spas are medical in nature, the ownership of these practices is governed by this doctrine. To see if your state follows the corporate practice of medicine check your state’s medical aesthetic legal summary.

As it relates to gift cards, this means that the payment for the gift cards must be made in full to a physician or physician-owned corporation; otherwise, the practice has engaged in fee-splitting, which is illegal in most states. 

Also, you may wish to reward employees or customers who bring in business with gift cards, but doing so in a medical setting, such as a medical spa, can represent a violation of state and federal anti-kickback laws, which prohibit practices from paying for referrals. Because gift cards have a cash value attached to them, they can be viewed as representing a kickback and, therefore, expose the practice to legal action.

A medical spa owner or operator must be mindful when he or she is giving out gift cards. If the person who receives the card is not paying for it, there must be clear understanding that is not being given for any business-related purpose. If you give gift cards only as tokens of your appreciation, you should be fine.

The holiday season is meant to be a joyous time; keep it that way by understanding and observing the rules and regulations related to gift card distribution.

Tags:  FTC  Gift Cards  Med Spa Law 

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FDA Guidance Offers Clarity on Microneedling Issues

Posted By Administration, Tuesday, November 7, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

The question of who can perform microneedling has been a hot-button one in spas and medical spas in recent years. On September 15, 2017, The U.S. Food and Drug Administration (FDA) issued a draft guidance to employees and industry professionals concerning its position on controversies concerning microneedling devices. The document, titled “Regulatory Considerations for Microneedling Devices,” clarifies the rules and offers definitions for a variety of microneedling products. It can be read and downloaded here.

Microneedling—also known as collagen induction therapy—is a skin treatment in which tiny needles are introduced to the skin, penetrating it in order to stimulate the production of collagen and other growth factors. It is relatively inexpensive, usually produces visible results without complications, and is easy to perform, so it has appeal both to medical aesthetic professionals and patients. (See AmSpa’s Treatment Directory for more information on microneedling.)

However, while this treatment is simple, the legal issues surrounding it are not, so it is important to understand why microneedling is such a controversial topic and why this document from the FDA is an important step toward clarity.

The controversy

Treatments that break the outer layer of a patient’s skin typically are considered to be medical in nature. This might seem to intrinsically make microneedling a medical procedure but, in fact, it is very difficult to judge whether or not the skin is being broken when you are dealing with tiny needles that can be as small as fractions of a millimeter long. Skin layer depth varies from patient to patient and depends on the part of the body being treated, as well as the amount of pressure being applied. 

Hypothetically, if microneedling is not a medical procedure, it could be performed by an aesthetician without an exam. However, if it is medical, a patient history must be taken, a licensed medical professional must administer an exam prior to treatment, and proper supervision and/or delegation procedures must be observed during the treatment. Put simply, if microneedling is treated as a medical procedure, it is far less profitable for the medical spa and far less convenient for the patient.

Getting to the point

This draft guidance is a big deal for the medical aesthetic industry. It offers some clarity regarding whether or not the manufacturers of certain microneedling devices need to be compliant with FDA standards, which gives some insight into the current attitudes of the agency and its partners regarding the nature of these treatments.

“Depending on the applicable state laws for scope of practice, delegation and supervision, this could result in medical spas having to reorganize their staffing for the performance of microneedling using newly classified devices,” says Jay D. Reyero, JD, partner at ByrdAdatto. “It could also result in transforming more traditional spas that feature microneedling into what we think of as medical spas.”

We advise everyone who is using microneedling devices at their medical spas to proceed with some caution, because there are FDA issues that are being worked through with regard to compliance. 

“We could see a clear distinction of what constitutes the practice of medicine for purposes of microneedling develop, giving medical spas more clarity on the issue,” Reyero says. “We could envision state licensing boards adopting a position to rely on the FDA’s determination and base a determination of the practice of medicine simply on the type of microneedling product used rather than the particular effects on the human skin or the lengths of needles.”

We anticipate that in the next month or two, the FDA will provide some clarification regarding these issues, but for now, it likely is best to proceed as if these treatments are explicitly medical in nature.

For other medical aesthetic legal questions be sure to seek legal advice from an attorney familiar with aesthetic laws in your state. AmSpaBasic members have access to a 60-question legal summary of regulations in their state, while AmSpaPlus members have access to these answers plus 25 additional questions. Become a member today to get answers to your aesthetic legal questions.



Tags:  Med Spa Law  Microneedling 

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Illinois Nurse Practice Act Update

Posted By Administration, Friday, November 3, 2017


By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

UPDATE: Gov. Rauner signed the revised Illinois Nurse Practice Act on Sept. 20. As stated in this post, it will take effect on Jan. 1, 2018. AmSpa will be conducting a webinar discussing the implications of this development on November 15, 2017 from 11:30am - 12:30 pm CST. If you own or operate a medical spa in Illinois, or if you live elsewhere and want to know how similar legislation might affect the industry in your state, register for the webinar today.

Tags:  Illinois Nurse Practice Act  Med Spa Law 

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Scary Patients Can Haunt Your Practice

Posted By Aly Boeckh, Tuesday, October 31, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Most of the people you encounter while working at a medical spa are perfectly pleasant, have reasonable expectations of their treatment, and are happy to discuss their options with you. However, at some point you will likely encounter a patient who asks too much of you or your business. Unfortunately, it is within that person’s power to make your life extremely complicated. It is important that you understand how to manage problematic patients to maintain your practice’s good reputation and prevent potential legal headaches.

A peculiar problem

Medical spa owners and operators face many challenges due to the nature of the medical aesthetic business.

Patients often may feel extremely entitled because they are paying out of their own pockets for their services instead of using insurance. Due to this entitlement, patients are often more demanding that in a managed care or traditional health care setting and there is a greater risk of the relationship ending badly. If a facility feels the need to initiate the termination of the relationship, some patients may be offended and may make legal complaints or turn to the state medical board.

This is unfortunate, but it is the nature of the industry. Sadly, some of these difficult patients simply cannot be reasoned with.

Oftentimes, because medical aesthetic services have to do with the physical appearance of patients, you may encourage patients with serious mental health issues related to their appearance, making them fundamentally unhappy with unrealistic expectations. 

Patient complaints to medical boards are no joke. Even if a claim such as this is eventually dismissed, a physician still must take the time and spend the money to defend him- or herself against it. And even if a physician is cleared of professional misconduct, his or her business still can be harmed by that former patient.
Medical aesthetic patients with mental instability also may be more likely to vent online in ways that can be professionally damaging on a number of social media sites, including doctor-rating websites. 

Combating complications

The best way to avoid having to confront issues concerning problematic patients is to make sure that you don’t associate with them in the first place.

Try to identify potential problem patients early on and figure out the best ways to encourage them to avoid your practice without offending them. This is where hiring the best front desk and customer care employees come in. They need to be trained on responses to handle and screen for potentially problematic patients, identifying red flags. These include patients who vent frustrations about previous doctors and patients who have unrealistic expectations about appearance changes they desire. Often, if you just listen to your patients, they will tell you everything you need to know.

It also is important that medical spas explain their policies as clearly as possible. A medical spa should team with an attorney to produce a contract for patients to sign prior to the administration of any procedures; this document should clearly present the conditions under which a medical spa will provide the prospective patient the service.

It is crucial that patients understand the expectations of the medical spa as clearly as the medical spa team understands the expectations of the patients. Patients needs to understand that they will not be allowed to disrespect medical spa procedure, such as not showing up for appointments, not adhering to instructions for preoperative treatments, making threats or are disruptive in the office environment and not paying for their treatment in a timely manner. Clarity and enforcement are critical to successful patient relationships.

Medical spas also can prepare themselves for the problem patients by making sure that their malpractice insurance contains language that protects them from spurious legal action.

“If a complaint is filed against a person and a governmental body comes in and decides to investigate, there’s a provision within a malpractice policy that is referred to as administrative defense coverage,” said David Shaffer, vice president of Professional Medical, the health care division of Insurance Office of America. “It basically provides the insured with reimbursement coverage for the cost of the investigation itself.”

Targeted coverage that can help to protect against unwarranted social media attacks is also available.

“One of the perks that’s built into the AmSpa [Medical Spa Insurance] Program is reputational harm coverage,” Shaffer said. “A consultant is made available when coverage is triggered to help them go out and perform whatever services are necessary to rebuild that reputation or correct whatever wrongs may have been put out there by a disgruntled patient.”

However, this coverage is only triggered if a claim is associated with the perceived damage—little can actually be done if an irrational patient smears a physician or spa via social media without filing a complaint. Again, your best defense is to avoid treating people patients such as these.

It is also worth noting that, in my experience, many problem patients come to med spas via deal sites such as Groupon. If you are considering partnering with a site such as Groupon to get the word out about your med spa, you may want to consider the quality of client these promotions sometimes attract. 

Being human

Even if you implement strict upfront screening practices and provide explicit terms and conditions for your services, you may still encounter patients with whom you feel you need to part ways. If this happens, talk to the patient with empathy and make sure he or she understands that you feel you are working in his or her best interests.

Tags:  How to Deal with Bad Patients  Med Spa Law 

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Streaming Surgeries Raise Issues for Medical Spas

Posted By Administration, Thursday, October 26, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)


Can you­–and should you–live-stream medical procedures on social media? Recently, some of the most prominent plastic surgery societies—most notably the American Society of Plastic Surgeons (ASPS)—have begun to take a look at some of the ethical questions surrounding plastic surgeons broadcasting live video of the procedures they conduct on social media services such as YouTube and Facebook. The surgeons who stream these surgeries typically say that they do this for its educational value, but clearly these shows are also designed to raise the surgeon’s profile. If the doctor successfully publicizes the event, several thousand people will tune in, and sometimes a staff member will even be in the operating room with the surgeon answering questions from the video’s chat function on a computer.


There is nothing illegal or even necessarily unethical about this but, on occasion, these videos make the surgeon and his or her staff look unprofessional, especially if they are joking around or goofing off during the procedure. And while gimmickry such as this is almost expected from those posting to social media today, it certainly can be argued that medical professionals should hold themselves to a higher standard. If the purpose of the video truly is to educate rather than make the surgeon a social media superstar, this sort of behavior should not be highlighted.


A matter of respect


At AmSpa’s Boot Camps, we often point out that in the medical aesthetic field, it is very important to incorporate sales and marketing techniques into the every day operation of a practice—certainly moreso than one would in a traditional medical setting, such as a doctor’s office or a hospital. After all, medical aesthetics is a retail business, and if those in a retail business do not pay attention to this aspect of the operation, they are not likely to be in business for very long.


To that end, live streaming is an effective way for surgeons to get their practice’s name on peoples’ lips. But while we typically encourage medical spa owners and operators to engage in marketing techniques such as these, we feel that those who act foolishly in videos need to take stock of just how far they’re going and make sure that they’re still representing medicine in a professional manner. They also need to make sure that they’re acting in a manner that is respectful to their patients, who often are unconscious on the operating table—it just looks bad when doctors are dancing, joking, and saying silly things to the camera while the patient is prone. It’s easy for surgeons to lose sight of this when they are performing (because a live broadcast of a surgical procedure realistically is a performance), but it is something they should make a point to be mindful of. This is a competitive market in which many people are utilizing unorthodox sales techniques and, although medical aesthetic professionals have to ensure that a practice remains profitable, they are still dealing with medical patients.


Contracting trouble


While this should probably go without saying, it is critically important that any surgeon or medical spa planning on live-streaming a surgical procedure receives written consent from the patient that thoroughly covers all HIPAA and local patient privacy laws. The forms used for this must be very specifically drafted in order to address the legal minutiae of live-streaming a medical procedure, so anyone planning to do this needs to be very careful to ensure that the patient understands exactly what is going to happen. This is not the sort of form that anyone can simply download off the Internet—it will need to be vetted by an experienced health care attorney to guarantee that no legal entanglements result from this broadcast.


Again, it’s worth mentioning that when patients sign such an agreement, they are consenting to the doctor streaming video of the procedure and to having their likenesses out there for the world to see for educational purposes, not to being a motionless prop while the surgeon acts foolish. It’s not hard to imagine a scenario in which a patient would be fine with participating in an educational live-stream, but then appalled when he or she sees the surgeon and staff members messing around during the actual video.


Living with a low profile


There is a very strong division in the realm of plastic surgery between those with the old-school mentality that any sort of self-promotion is gauche and those who have no problem with marketing themselves. Medical spas are caught in the middle—they are mostly run by non-core doctors and, in order to compete, they often are forced to engage in promotional techniques that some medical professionals might find unsavory.


I think it is important for medical spas to be a responsible party and to not promote stunts that are too overblown, because if they do, there will be blowback if something goes wrong or a patient files suit because he or she feels misled. Those doctors with anti-promotional mind-sets will use the opportunity to try to take certain procedures out of medical spas’ hands. The medical spa industry needs to be careful—it shouldn’t get too brazen or overt with its marketing, because medical societies have much louder voices in halls of government than the medical spa industry does. A group of Northwestern Medicine authors recently proposed a code of ethics for videos, and I think this is a good idea. After all, if these videos truly are for educational purposes, they don’t need the theatrics.

Tags:  Med Spa Law  Streaming Surgeries 

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Corporate Practice of Medicine Issues in Illinois Medical Spas

Posted By Administration, Tuesday, October 24, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)


The laws about owning a medical spa in Illinois are not necessarily straightforward, but are increasing in importance because the state is a hotbed for the medical aesthetic industry. If you travel in and around the bustling city of Chicago, you may find yourself overwhelmed by the number and variety of medical spas in the area. However, likely due to the size of the industry in the state, Illinois has become known as one of the most active states in the nation in terms of regulatory investigation of medical aesthetic practices.


Ownership is one of the key factors that Illinois regulators look at continuously—they are very concerned with who owns and collects revenue from the state’s medical spas, and they are quick to punish those whose ownership structures are found to not meet the requirements of Illinois law. Therefore, it is important for Illinois medical spa owners—and prospective Illinois medical spa owners—to know what constitutes a legal ownership structure in the Land of Lincoln, since laws can vary greatly state-to-state. (AmSpa Members: Consult your legal summary to find answers to Illinois medical spa ownership questions.)


Corporate practice of medicine


Illinois observes a legal doctrine known as the “corporate practice of medicine,” which dictates that a physician or a physician-owned corporation must be the sole owner of a medical facility in the state. Since medical aesthetic practices are medical facilities—unorthodox medical facilities, but still—they are required to adhere to this standard. Additionally, only physicians or physician-owned corporations can collect revenue from medical procedures administered, and non-doctors—including nurses, estheticians, and entrepreneurs—cannot employ or contract with doctors to serve as their medical director and then collect revenue from medical spa services. This is designed to ensure that physicians are in complete control of all medical treatment; this extends to the pricing of procedures and the purchase of medical supplies and drugs. In the eyes of the state, a doctor should always have control of these factors and, if one is not, the pursuit of profit will win out over the welfare of the patients.


The arrangement that tends to get people in trouble in Illinois is when an entrepreneur, a nurse, or an esthetician opens a medical spa and enters into a medical director contract with a doctor. If a non-doctor accepts payment for medical services, it is a violation of the corporate practice of medicine, even if the doctor is heavily involved in the day-to-day operation of the facility (which is not always the case with medical directors). In such a case, the revenue—and, therefore, a degree of control over medical treatment—flows to a non-doctor, which is prohibited.


A solution


If an entrepreneur or a nurse wants to become a part of the medical aesthetics industry on an ownership level in Illinois, he or she can look into setting up a management services organization (MSO). An MSO partners with a physician, for whom a separate company is created; this company only provides medical services. This arrangement is known as a management service agreement (MSA) and essentially allows a non-physician to supervise almost every aspect of a medical aesthetics business, including branding, marketing, owning the real estate, payroll, human resources, accounting, and billing—everything except the actual administration of medical services, for which the physician remains solely responsible.


Essentially, this is best thought of as a lessor/lessee situation. The physician pays the MSO “rent” for the right to occupy the space, and the MSO as a landlord, maintaining the facility and keeping the physician as comfortable as possible. However, the amount paid to the MSO fluctuates according to the amount of business conducted by the physician. If the medical organization conducts more treatments in a month or quarter (depending on the terms of the agreement) than it did the previous term, the MSO also will make more money. This helps to create a bond between the physician and the MSO—if one succeeds, they both succeed. 


Words of warning


Often, AmSpa consults with nurses and entrepreneurs regarding the corporate practice of medicine issues in Illinois, but it is equally as important for non-core doctors—surgeons and general practitioners, for example—who are becoming medical directors to watch out for this. Ultimately, they can have their licenses investigated because of this doctrine. In this space in the future, we will discuss some recent court cases in states such as Michigan and New Jersey, in which there have been severe consequences for violating the corporate practice of medicine—contracts have been invalidated, insurance payments have been recouped, and coverage has been denied. This is a real issue that medical aesthetic professionals need to be aware of. To be sure you are on the right side of medical spa law consult an attorney familiar with medical aesthetic regulations in your state.

Tags:  Illinois Corporate Practice of Medicine  Med Spa Law 

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Who Can Legally Fire a Laser In Georgia?

Posted By Aly Boeckh, Tuesday, October 10, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

The issue of who can and cannot legally operate cosmetic lasers troubles many medical spa and medical aesthetic facility owners and operators. After all, there is no universally accepted licensing procedure for cosmetic laser technicians, and most state medical boards have not taken the time to rule on the subject. However, the Georgia Composite Medical Board has been proactive in addressing the idea that cosmetic lasers are something of a hybrid of medical and non-medical treatment, and it offers cosmetic laser practitioner licenses that permit estheticians, registered nurses, and cosmetologists to legally fire lasers under certain circumstances.

Peachy keen

It is difficult for some medical spa owners and operators to come to terms with the fact that some non-invasive laser treatments are considered medical treatments, and therefore require a physician, nurse practitioner (APRN), or physician assistant (PA) to not only perform an initial consultation, but also fire or supervise the firing of the laser. To many, this seems like an unnecessary use of these medical professionals’ time and resources.

The Georgia Composite Medical Board decided to address this issue by creating a state licensure procedure to clarify who can legally fire certain types of cosmetic lasers, and what procedures need to occur in advance of these treatments. 

First of all, it is important to clarify that this licensure covers only a few types of cosmetic laser treatments: laser hair removal, intense pulsed-light devices, and non-ablative light-based devices. All other cosmetic laser treatments are beyond the scope of this licensure and must be treated as medical procedures, with accompanying initial exams and proper supervision. However, the simple, relatively inexpensive cosmetic treatments this licensure does cover account for a large percentage of the laser treatments administered in the U.S., so the impact of this licensure can be significant.

Georgia’s law creates two levels of cosmetic laser practitioner licenses:
Assistant laser practitioner: This license allows people who hold licenses as PAs, licensed practical nurses (LPNs), APRNs, registered nurses (RNs), estheticians, and master cosmetologists to conduct the cosmetic laser treatments mentioned above without a doctor seeing the patient first or a even being on site. In order to earn this license, a candidate must complete certain courses from accredited laser training schools and meet certain requirements from the state.

A licensed assistant laser practitioner does not require any supervision when performing the treatments covered in this license, which helps improve a medical spa’s flexibility. Having a physician onsite to supervise basic treatments such as these is a major hurdle that these businesses have to clear in order to improve their profitability, and Georgia has provided the mechanism to make that possible. 

Senior laser practitioner: This license permits PAs, RNs, and APRNs to supervise unlicensed individuals who are firing lasers. If an LPN or esthetician, say, does not have an assistant laser practitioner license and a physician is not onsite to supervise, an RN with a senior laser practitioner license does provide sufficient supervision from a legal standpoint, thanks to this aspect of Georgia law. Again, this gives the practice the ability to treat a patient without needing a doctor to see him or her, which could potentially save it a great deal of money. 

As with the assistant laser practitioner license, someone seeking a senior laser practitioner license must complete training courses from state-approved laser training schools. In addition, he or she must have at least three years of experience, as well as three years of clinical or medical technological experience.

The laser’s edge

From AmSpa’s perspective, the availability of these licenses is a major positive, because it provides some clarity in an area of medical aesthetics where, often, there is none. It’s something we in the legal profession always seek—a definitive statement that illustrates exactly what one must do to be compliant. We’re always supportive of efforts by a legislature or medical board to clarify things that need it.

Also, this law creates the potential for medical spas and laser centers in Georgia to see more patients, as well as potentially open more locations with a higher patient flow, because they don’t need to circulate the patients in to see a doctor or NP. However, this still only addresses a small number of laser services, so if you operate in Georgia and have questions about remaining compliant while administering other laser treatments, consult your local health care attorney or work with AmSpa’s national law firm, ByrdAdatto. AmSpa members can view the Georgia legal summary to get an overview on the state’s medical aesthetic laws.

To learn more about this law and others that affect medical spas in the Peach State, sign up to attend AmSpa’s Boot Camp in Atlanta on November 6 and 7. Click here for more information and to register for the Boot Camp. We hope to see you there!

Tags:  Med Spa Law 

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