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How Core Doctors Can Overcome Generational Differences in Marketing, Advertising and Ethics, Part 2

Posted By Administration, Monday, June 10, 2019

vlog doctor

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

(Click here to read part 1)

Streaming video of procedures has helped many core doctors make names for themselves on social media and the internet, but this practice is understandably the source of a great deal of controversy. Recently, some prominent plastic surgery societies have begun to consider the ethical questions surrounding plastic surgeons broadcasting the procedures they perform on social media services, such as YouTube and Facebook. The doctors who stream these surgeries often say that they do this for its educational value, but these shows are also designed to raise the surgeon’s profile. If the event is properly publicized, 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. This can lead to a great deal of income for the surgeon.

There is nothing illegal or even necessarily unethical about this but, on occasion, these videos make the surgeons and their staff members look unprofessional, especially depending on how they act during the procedure. While acting silly is almost expected from those engaging in social media today, it 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 raise the surgeon’s profile, this sort of behavior should not be highlighted.

At the same time, it is undeniable that live streaming is an effective way for a surgeon to get his or her practice’s name on people’s lips. It also makes prospective patients comfortable with the surgeon, provides answers to questions that many patients have, and promotes plastic surgery as a whole. And if you ask the surgeons themselves, many who live-stream can point to a direct correlation between their marketing efforts and a sharp increase in revenue.

However, while it’s understandable that medical aesthetic doctors engage in marketing techniques such as these, those who make videos must make sure that they’re still representing medicine in a professional manner. This is still the practice of medicine, after all. 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 looks bad when doctors are dancing and joking while the patient is prone (yes, this has actually happened). It’s easy for a surgeon to lose sight of this when he or she is performing (because a live broadcast of a surgical procedure realistically is a performance), but it is something he or she should make a point to be mindful of. This is a competitive market in which many people are utilizing unorthodox sales techniques and, while medical aesthetic professionals have to ensure that a practice remains profitable, they are still dealing with medical patients.

Crossing Ts, Dotting Is

Although this should probably go without saying, it is critically important that any surgeon or medical spa planning on conducting a social media campaign receives written consent from featured patients that thoroughly cover 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 social media, 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.

Again, it’s worth mentioning that when he or she signs such an agreement, the patient is consenting to having his or her likeness out there for the world to see for educational purposes, not to being a motionless prop while the surgeon or his staff members act foolish. It’s not hard to imagine a scenario in which a patient would be fine with participating in a social media campaign or educational live-stream, but then appalled when he or she sees the surgeon and staff members goofing around during the promotion. The end result may not be covered by the consent form the patient originally signed.

Direct Messages

So is it inherently bad for plastic surgeons to become social media celebrities? Isn’t that the goal of marketing and public relations? It probably doesn’t matter – the genie isn’t going back in the bottle and the industry is going to need to figure out how to deal with it. There are numerous questions that societies should be asking themselves, particularly given the number of non-core doctors entering the industry. Any physician can establish himself as an expert by virtue of social media and internet advertising, but it can be problematic when the physicians in question are young and perhaps doing work that they aren’t quite qualified to be doing. If patients are receiving misrepresentative information from these doctors—and if we’ve learned anything in this country in the past couple years—it’s that people tend to believe what they see on television and social media, and that can be extremely dangerous.

At this point, dealing with this issue seems to be about making the use of social media acceptable from an ethical standpoint. There really is no turning back—social media has become a key part of marketing for core doctors, no matter how badly some wish it weren’t true, and it isn’t going anywhere.

The bottom line is that the medical aesthetic industry needs to be careful—it shouldn’t get too brazen 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, for example, and I think this is a good idea. After all, if these campaigns truly are for educational purposes, they don’t need the theatrics. But at the same time, the ability of medical spas to market themselves aggressively is one thing that sets them apart and allows them to succeed in a very crowded marketplace. And the personalities of practitioners come through in social media campaigns, and often the providers become much more relatable than their surgeon counterparts. There is a delicate balance that must be struck and, if the industry is going to survive, it is imperative that we make this balancing act a priority.

To stay updated on this issue and learn about many others, become an AmSpa Member and schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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How Core Doctors Can Overcome Generational Differences in Marketing, Advertising and Ethics, Part 1

Posted By Administration, Friday, June 7, 2019

doctor vlogger

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

Core doctors—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and dermatologists—are, as their moniker suggests, the center of the medical aesthetic industry. As physicians, they are allowed to own and operate medical spas, and their fields of expertise coincide with many of the procedures sought by those who frequent these businesses. Historically, core doctors have made a lot of money by operating medical spas along with their more traditional practices.

However, in recent years, younger core doctors, nurse injectors and medical spa owners have courted controversy by stepping outside the role of humble healer that physicians traditionally take on, and into another role—celebrity provider. These doctors do not hesitate to market themselves and their businesses in ways that some older physicians find gauche and undignified, and they have created a great deal of controversy in the medical community by doing so. This generation gap must be addressed, but the issues at the heart of the matter must first be understood by both sides.

Social Studies

Younger core doctors primarily market themselves with social media sites such as Twitter, Instagram, and Facebook. The use of social media is a very different form of promotion than what many core doctors are used to, and it can be difficult for more traditional doctors to wrap their heads around what it is and what it does.

Because medical aesthetics has become so lucrative, it has arguably moved away from more traditional medicine. While traditional rules and traditional ethos apply, aesthetic medicine is governed in many ways by a completely different dynamic—aesthetic treatments are all voluntary, they are all cash-based, and there is a great deal of competition. Doctors are taught the Hippocratic Oath and other ethical ideals that have governed the profession for millennia. But when people choose to undergo surgery for purely cosmetic purposes, medical providers are no longer healing a patient per se, but rather providing the patient with a service that is advertised and sold on the open market. So, how do you take medical ethics that are designed to help cure disease and apply them to a competitive industry where patients shop for—and doctors sell—treatments that address patients’ desire to change the way they look?

The medical aesthetics industry also intersects with technology and marketing in ways that traditional medicine does not, which has contributed to this discord. It’s not entirely generational—there certainly are younger doctors who believe that the actions of some core doctors are a bit over the top, and there are older doctors who have bought into social media—but there clearly is a generational line between some of the older plastic surgeons who were trained in a time where marketing their practice, and themselves, was not as important as it is now. For many, the medicine and science behind plastic surgery has been subverted by the need for views, shares and likes. These surgeons feel that many in plastic surgery are missing the point of what it means to be a surgeon, and that the need for celebrity has overtaken the need to practice medicine.

But in today’s world, particularly among younger surgeons who have been using social media for years, the idea of not marketing yourself is unthinkable. In their world, one must adapt or die, and failure to compete in the marketplace through use of social media, video and marketing is the easiest way to make your practice extinct. Although there have always been surgeons who are at least somewhat famous, with social media and reality television becoming ubiquitous in recent years, this has been taken to a whole new level. With social media especially, celebrity has become democratized, and physicians can become famous through sheer hustle. There are young surgeons who have become far more famous than their older counterparts purely by utilizing the social media tools at their disposal, and this has, to some extent, disrupted the established order and ruffled some feathers. So the question must be asked: Is this merely the competitive marketplace shaking itself out or has aesthetic surgery crossed the line into something more problematic that needs to be reined in? It depends on who you ask.

(Check back on Monday morning for part 2)...

To learn more about the legalities that govern medical aesthetics, sign up for an AmSpa Boot Camp. You will learn how to operate your medical spa compliantly and profitably.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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How to Stay Compliant When Using Social Media Influencers

Posted By Administration, Wednesday, June 5, 2019

influencer

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

As is the case in most industries, the use of social media influencers to promote medical aesthetics is extremely common. However, because medical spas offer medical treatments, the regulations that govern influencer marketing in this space are more stringent than with many large brands you might see represented on Instagram, YouTube or other social channels.

The power of social media influencers is undeniable. If an influencer goes to a medical spa for a treatment, he or she may film the entire visit and broadcast it throughout the world on his or her social media channels. If the influencer has a significant following, this can have a major impact on a medical spa’s business.

However, most of these visits are not spontaneous situations. More often than not, medical spas compensate influencers with cash and/or free treatments to get them to portray their practices in a positive light. If your medical spa is engaging in this sort of advertising, you need to understand the legal issues surrounding these matters, although in most cases, precedent has yet to be established, as these transactions are occurring in a new medium.

Written Agreements

If a medical spa uses an influencer to promote the practice, it must have a written agreement with the influencer in place. This agreement should dictate what the influencer’s responsibilities are—how many times he or she is going to post about the practice and what he or she is going to post. The medical spa should have as much editorial control over the posts as possible, since the influencer’s primary goal is to promote his or her brand—not yours—and the medical spa is responsible for keeping the influencer on message. The deal must meet the medical spa’s expectations to ensure that it’s getting its money’s worth. Even if you’re compensating the influencer with a treatment, you need to make this as clear as possible, and a written agreement will help both sides understand the nature of the deal. This also helps you to assign a value to the services you are providing.

Advertising Rules

As a medical provider, when you compensate someone to promote your brand, you are subject to medical advertising rules and regulations, which are much stricter and have much more dire consequences for violations than common advertising rules. Primarily, this means you cannot say anything that can be construed as misleading, untrue, aggrandizing or exaggerated—everything that’s said about your medical spa must be provably true. You can’t simply say that you’re the best injector in the world, for example, because you can’t prove that. That advertisement is asking for trouble.

When influencers are being paid—or given free treatments—to represent your medical spa, they are legally acting as a paid advertiser. As such, you’re responsible for everything they say, so if they say something hyperbolic, you are responsible for that message, and the situation can get very sticky if a medical board finds out about it. You will need to make sure that the influencer understands that the medical spa is subject to these restrictions and that he or she must be sensitive about precisely what is said in these videos or blog posts. With a written agreement, you can disclaim some of these factors, which allows you to exert some control over the message.

Disclosure Guidelines

Influencers also have their own set of guidelines to worry about. In 2017, the Federal Trade Commission (FTC) issued warnings to more than 90 social media influencers who failed to disclosure when they were being compensated in exchange for coverage, and reiterated its guidelines for compliance. These include:

  • Keep your disclosures unambiguous;
  • Make your disclosures highly visible; and
  • Avoid hard-to-read, buried disclosures in strings of hashtags that are skipped by readers.

Influencer marketing can be a very powerful promotional tool, but it must be wielded with some care in order for your medical aesthetics practice to remain compliant. As I mentioned earlier, the legal aspect of its use in a medical setting is still developing, so if you’re unsure about how to proceed, be sure to consult with an experienced health care attorney.

For more information about utilizing social media to build your practice and about the laws governing medical aesthetics, sign up for an AmSpa Medical Spa & Aesthetic Boot Camp.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law  Med Spa Trends 

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Do Websites Need to Be ADA Compliant?

Posted By Administration, Friday, May 31, 2019

type to speech device

By Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

In the recent past, you may have heard about or received correspondence threatening a lawsuit because someone claimed your website was not compliant with the Americans with Disabilities Act of 1990 (ADA). You may wonder, “Is this real?” or “Does this apply to me?” Yes, it is real, and it probably applies to you.

Title III of the ADA prohibits discrimination on the basis of disability in the goods and services offered by places open to the public. These places are referred to as “public accommodations” and include hotels, restaurants, stores and health care providers. For our purposes, medical spas, doctor’s offices and other medical facilities would count as public accommodations under Title III of the ADA. The ADA requires that these public accommodations be accessible to persons with disabilities, whether that means providing wheelchair ramps or providing appropriate auxiliary aids to ensure effective communication with people with disabilities. And as a recent U.S. Department of Justice (DOJ) letter makes clear, these accessibility requirements extend to a public accommodation’s website.

So we know that websites need to be “accessible” to be compliant with the ADA requirements. In order to do that, however, website owners need to know what compliance entails. Unfortunately, the DOJ has yet to release any accessibility guidelines or standards for websites. As the above letter states, the DOJ had previously announced that it would be adopting third-party accessibility standards, but it withdrew those plans in late 2017. Now it seems that the DOJ will not be releasing any guidelines soon, choosing instead to encourage Congress to pass legislation in this area.

This leaves website owners in a tight spot, as the lack of adopted guidelines does not relieve their duty to be compliant with the ADA. Fortunately, some resources are available to help. The third-party guidelines the DOJ had tacitly endorsed previously are known as the Web Content Accessibility Guidelines 2.0 (WCAG 2.0). These are most certainly not official, and complying with them does not necessarily mean that you are compliant with the ADA. However, they do provide good information about making sure that your website content can be perceived, interacted with and understood by people with disabilities. This can include making sure that menus and website content can be read by text-to-speech devices or braille displays.

A website may need to take fewer steps than the WCAG 2.0 suggests, or it may need to take more.  Future details will come from Congress, the DOJ or court decisions. The most prominent website accessibility case thus far was recently heard by the Ninth Circuit Court of Appeals. In Robles v. Domino’s Pizza 2019, the plaintiff, who is blind, was unable to order a pizza through the Domino’s website because the website was not sufficiently readable to his text-to-speech system. The Ninth Circuit Court of Appeals reversed the lower court’s ruling for the defendant, Domino’s, which had been decided on preliminary issues. The Robles case will now head back to trial, where we may learn more about specific nuts-and-bolts rules for website compliance.

However, website owners should start compliance reviews and changes to their websites now. The more compliant a website becomes, the less chance it will receive a demand letter or be subject to a lawsuit.

To stay updated on this issue and learn about many others, become an AmSpa Member and schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  Med Spa Law 

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How to Find Legal Answers for Your Medical Spa

Posted By Administration, Wednesday, May 29, 2019

lawyer and statue

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

At AmSpa and ByrdAdatto, we are asked every day about the legalities of the medical aesthetic industry. We constantly hear from professionals wondering, for example, if an aesthetician can perform a particular procedure, or whether a licensed vocational nurse can inject a certain product, among many others. The number and types of questions we receive speak to the complexities of the industry.

Providing information such as this to medical aesthetic professionals is the reason why AmSpa was started in the first place, but people often question our conclusions or wonder why, if the law is what we say it is, no one is following it. As it turns out, finding legal answers in the medical aesthetic industry is not easy, and the answers themselves are not simple, and there are numerous reasons why.

Some conversations about the legalities of the industry repeatedly occur. For example, I will explain the requirement that a physician, physician assistant or nurse practitioner perform a face-to-face examination of a patient before a laser treatment or filler injection, and the person with whom I’m speaking will say that can’t be true—nobody does that. If that is what’s required, they say, you could shut down every medical spa in the state for violating this law. But it is true, it is the law, and yes, a regulatory agency probably could shut down most medical spas in a given state if it had the manpower to investigate them all.

The medical aesthetic industry is unique in many ways. First of all, its procedures are all elective, so medical spas must market to people who choose to undergo their procedures rather than require it. Also, medical spas do not deal with insurance—the industry is entirely cash-based. Because of these factors, medical spas have to market themselves to a degree that traditional medical outlets do not.

As a result of this need for effective marketing, non-physicians play key roles in the health of these businesses. For example, a registered nurse who is a skilled injector can be the person patients come to see, as opposed to the physician. This is a much different dynamic than can be found anywhere else in the world of medicine.

Additionally, medical aesthetic practices typically have to deal with multiple practice groups, including medical boards, nursing boards and boards of cosmetology. And because the medical aesthetics industry is so young, many of these agencies are dealing with questions that are being raised for the first time. Essentially, the industry is governed by laws that are not designed to govern it and people who are more concerned with other issues.

For example, nursing boards probably won’t have too much to say about CoolSculpting, since much of their time is spent dealing with pressing matters such as opioids. They have so much to deal with that they can’t reasonably be expected to understand the nuances of the medical aesthetics industry.

When AmSpa researches the laws that apply to medical aesthetics practices in a particular state, we start by finding what we can in the state’s legislation, but most of the time, these laws’ use in relation to medical aesthetic situations is tangential; they’re typically written to deal with other areas of medicine and nursing. Therefore, regulatory interpretation of these laws with regard to medical aesthetics is vital. If a board has not published an opinion on a matter, that does not necessarily mean it does not actually have an opinion—it means that it has not yet presided over an incident that has caused it to issue an opinion. When you’re dealing with multiple boards with multiple opinions, the situation is further complicated.

All this makes AmSpa’s job very challenging. Usually, we have to take what we know about the laws and the boards and try to determine what a ruling would be. When we say, “This is what we believe the rule is in this particular state,” it’s unlikely that it is taken directly from legislation, because there’s a good chance that specific legislation doesn’t exist. We can, however, combine precedents with our legal knowledge to give you the most complete possible interpretation of the situation.

Our attorneys have been researching these regulations for years. They have appeared before nursing and medical boards to argue cases, and they have spoken with officials about these issues. This is how we learn about these issues. It’s very difficult work, but we’re confident that our attorneys provide our members the best possible information.

For more information about med spa laws, become an AmSpa Member to schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Join AmSpa at the Asheville Medical Spa & Aesthetic Boot Camp EXTRA

Posted By Administration, Friday, May 24, 2019

asheville omni hotel

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

Starting next Saturday, June 1, AmSpa will host its Asheville Medical Spa & Aesthetic Boot Camp EXTRA at the Omni Grove Park Inn. We’re extremely excited for the opportunity to help medical aesthetic professionals develop their practices in this beautiful setting. There’s still time to register for the event—just click here to sign up. Here is a quick overview of the program:

Saturday, June 1

The Boot Camp begins at 8 a.m. with a continental breakfast, followed at 8:30 a.m. with my opening keynote. From there, we will move into the main program:

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 11 – 11:30 a.m.: The Marketing Plan, presented by Terri Ross (Terri Ross Consulting)—Renowned medical spa consultant Terri Ross shows you how to most effectively market your practice using market research and defining your objectives.
  • 11:30 a.m. – 12:30 p.m. The Social Media Plan, presented by Danielle Smith (Smith & Popov)—This session will help you determine how to promote your medical aesthetic practice using cutting-edge social media techniques.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Renee E. Coover (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4 – 5 p.m.: The Lessons, presented by Louis Frisina—Every medical spa is different, but the successful ones share several common traits. In this session, Business Strategy Consultant Louis Frisina discusses the qualities that are typically found in practices that bring in a significant amount of revenue.
  • 5 – 6 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.

Saturday will wrap up with a cocktail reception from 6 – 7:30 p.m.

Sunday, June 2

Once again, the Boot Camp begins at 8 a.m. with a continental breakfast.

  • 8:30 – 9 a.m.: Anatomy of a $5-Million Med Spa, presented by Alex Thiersch (AmSpa)—Have you ever wondered what the difference is between your medical spa and one that’s mega-successful? It might be less significant than you think. This presentation will show what a $5-million med spa is doing right—and what you might be doing wrong.
  • 9 – 10 a.m.: The Financials, presented by Bryan Durocher (Durocher Enterprises)—At the end of the day, the money you’re bringing in is the most important measure of your practice’s success. This presentation will, among other things, demonstrate how to properly develop a budget and use metrics to determine your med spa’s strengths and weaknesses.
  • 10:30 – 11:30 a.m.: The Digital Marketing Ecosystem, presented by Audrey Neff (Crystal Clear Digital Marketing)—Find out how to effectively spread the word about your medical aesthetic practice and how best to determine what’s working and what’s not. Your practice’s digital presence is more important than ever before, and curating it should be a top priority.
  • 11:30 a.m. – 12:15 p.m.: Medical Aesthetic Hot Topics Panel, featuring Page Piland (Galderma), Audrey Neff (Crystal Clear Digital Marketing), Terri Ross (Terri Ross Consulting) and Nealy Skeldon (Environ Skincare)—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1 – 1:45 p.m.: The Consultation, presented by Terri Ross (Terri Ross Consulting)—As the old saying goes, you never get a second chance to make a first impression. Learn how to put your best foot forward with effective patient consultations—and how to turn them into consistent business.
  • 1:45 – 2:45 p.m.: The Long-term Revenue, presented by Bryan Durocher (Durocher Enterprises)—Simply being successful isn’t enough for a medical aesthetic practice; you have to know how to maintain and grow your success. In this session, Bryan will show you how to build patient loyalty and move your business forward.

Monday, June 3

The Boot Camp begins at 8:30 a.m. with a continental breakfast.

  • 9 a.m. – 12 p.m.: Making Money in Your Medical Spa, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and get a preview of The Roadmap to a 7-figure Medical Spa—Terri’s sales training course—which will show you how to convert web leads and develop phone skills, both of which are vital to medical spa success.

Also, you’ll have the chance to visit with a number of exceptional vendors throughout this event. Attend the Asheville Medical Spa Boot Camp EXTRA to check out the latest and greatest from the following companies:

We hope you can join us in Asheville next weekend. This AmSpa Boot Camp is a tremendous opportunity to get your medical aesthetic business headed in the right direction and learn some tips and tricks that can take it to the next level. Click here to register!

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law  Med Spa Trends 

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What You Need to Know About Parallel Importation

Posted By Administration, Wednesday, May 22, 2019

package delivery

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

In June 2018, Oregon-based physician Brenda Roberts had her medical license revoked for obtaining and using prescription medication from foreign countries. Roberts was a family practice doctor who was administering Botox treatments at her home on the side. She wasn’t necessarily doing anything inappropriate in terms of patient care, and she kept detailed records on her patients, but she was buying Botox from United Pharmacies—a “rogue pharmacy” that operates outside of U.S. Food and Drug Administration (FDA) governance—because Allergan noticed it was sending Botox to her home and cut off her account. FDA agents went through her trash and found that the Botox she used was intended for sale in Europe.

Roberts was participating in a practice called parallel importation, and while it is extremely enticing for medical spa owners looking after their bottom lines, it should be avoided at all costs, as Roberts’ case demonstrates.

A Controversial Practice

In countries such as the United Kingdom, Germany, France, Sweden and Canada, governments regulate the cost of pharmaceuticals. These measures are ostensibly designed to prevent drug manufacturers from charging excessive prices for essential medicine, but they also apply to pharmaceuticals used for elective procedures, including Botox.

In the U.S., however, FDA does not regulate drug prices, so drug manufacturers essentially can charge whatever they feel the market will bear for their products; that price is invariably much higher than what is charged in countries that have cost controls.

Because of this, it has become somewhat common for U.S.-based providers to buy drugs from licensed dealers in countries where cost controls are enforced. The prices are up to 50% lower than what the buyers would have to pay if they were purchasing the drugs directly from the manufacturer.

Both parties benefit from this arrangement. The buyers get legitimate pharmaceuticals for much less than they would pay if they bought directly from the manufacturers, and the dealers can make their money simply by marking the product up slightly. These are not counterfeit pharmaceuticals like the ones that are typically manufactured in China that have flooded the market in recent years—these are almost invariably the same drugs that are approved by the FDA and sold in the U.S.

Understanding the Rules

While parallel importation of consumer goods is broadly legal in the U.S.—the Supreme Court ruled that to be the case in a 2013 case involving textbooks—Roberts’ case demonstrates that the distribution of drugs that are not explicitly intended for use in the U.S. is absolutely illegal, and that FDA and the U.S. Drug Enforcement Agency (which also participated in the investigation) are taking cases such as this extremely seriously. There hasn’t been much enforcement yet, but this demonstrates that the issue is definitely on the agencies’ radars.

Despite the relatively low risk of being caught, ByrdAdatto and AmSpa steadfastly believe that medical aesthetics practices should not participate in parallel importation. The potential consequences definitely outweigh the cost savings. If your practice’s profitability depends on buying cheap drugs, you need to re-evaluate the way you do business. Practices should remain compliant with FDA and other regulatory agencies, regardless of whether they think a drug is overpriced. It is absolutely possible to run a medical aesthetic practice that is both very profitable and compliant with all laws and regulations.

If you need more information about parallel importation, consult with your healthcare attorney. AmSpa members can take advantage of their annual compliance consultation with ByrdAdatto. You can also learn the keys to running a medical spa practice profitably and compliantly at an AmSpa Medical Spa & Aesthetic Boot Camp.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  ByrdAdatto  Med Spa Law 

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What Is Required of a Medical Spa’s Good Faith Exams?

Posted By Administration, Tuesday, May 21, 2019

doctor consultation

By Sam Pondrom, JD, Associate at ByrdAdatto

There are two points that we can never reiterate enough regarding med spas: They are medical practices, and many of the services they render are considered the practice of medicine.

Accordingly, it is a crucial first step for med spas to establish the physician-patient relationship and ensure that a med spa patient is a good candidate for the procedures he or she is seeking. This is the purpose of the good faith exam. Good faith exams go by many names, and, in fact, the term “good faith examination” has been replaced in many states’ laws. It is common to hear the good faith exam referred to as the “initial exam,” “physical exam” or “initial consult.” Regardless of the nomenclature, it is important to remember that the good faith exam is an encounter that must happen before a patient receives a treatment to assess their current condition, note their medical history and ensure they are fit for the procedure. The goal of the good faith exam is to make a diagnosis and determine an appropriate treatment plan for the patient.

Here’s what you need to know about the good faith exam:

  • Who can do it? The good faith exam must be performed by a physician, physician assistant (PA) or advanced practice nurse (APN). Typically, the PA or APN must be delegated the ability to perform good faith exams by their supervising or collaborating physician. Registered nurses (RN) may aid the physician, PA or APN in administering the good faith exam, but they cannot generate orders for treatment based on the exam. A physician, PA or APN would need to review the RN’s findings and generate the treatment plan and order.
  • What constitutes a good faith exam? The good faith exam proceeds in two parts: obtaining a patient’s medical history and performing an appropriate physical examination of the patient. The medical history is a brief account of the patient’s general lifestyle, medical events and on-going treatments that may contain relevant information regarding the patient’s health. The appropriate physical examination is an assessment of the patient’s physical condition, generally and specifically, of the areas where the patient will receive treatment.
  • When does the good faith exam need to be performed? The good faith exam should be performed prior to a patient receiving a treatment for the first time, but it does not have to be performed every time you see the patient. Especially in the med spa context, a treatment plan will likely encompass multiple treatments over a period of time. If a patient seeks additional treatments not covered in the initial treatment plan, the patient’s health substantially changes or enough time has elapsed since the initial good faith exam, a new good faith exam should be performed. It is a good rule of thumb that a good faith exam should be performed at least annually on a patient.

To learn about legal and business best-practices to keep your med spa compliant and profitable, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps and be the next med spa success story.

For more medical spa legal and business tips sign up for AmSpa’s email newsletter to receive business strategies, news and med spa law directly in your inbox.

As the youngest of three brothers, Sam Pondrom learned early on how to work effectively as part of a team. After graduating from Oklahoma State, an intrinsic sense of curiosity and a keen eye for details led Sam to work as an accountant for two Engineering-News Record top 40 construction firms. It was here where he honed his ability to analyze complex issues and craft clear, concise answers. Sam utilizes these skills to work in partnership with our clients to resolve their complex business and regulatory concerns in the most simple, straightforward way.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  ByrdAdatto  Med Spa Law 

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Understanding the Legalities of Off-Label Use

Posted By Administration, Monday, May 20, 2019

drugs

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

The use of pharmaceuticals for treatments that are not specified by the U.S. Food and Drug Administration (FDA) is known as off-label use. This is a somewhat controversial practice, and many in the medical aesthetic industry may not fully understand why this is the case. However, if physicians use common sense and the medical information that is available, they can avoid legal entanglements. Here are a few things to keep in mind when considering off-label use in a medical spa setting.

Considering Use

In most cases, it is legal for a doctor to use FDA-approved medications in ways that are different from what the label specifically mentions. For example, Botox originally was specified by the FDA for use in the treatment of incontinence caused by spinal cord injuries or multiple sclerosis, migraines, upper limb spasticity, pain caused by cervical dystonia, axillary hyperhidrosis (sweating), blepharospasm (eye spasms) in children with dystonia, and strabismus (crossed eyes) in children. The reduction of facial wrinkles is not on that list, but it became by far the most prevalent use of the drug, and over the past 15 years, Botox has received three indications for cosmetic use. It is typically up a doctor’s own medical judgment to determine if a medication can be used for other treatments.

Also, it’s worth keeping in mind that the FDA does not govern the practice of medicine; it governs drugs. State medical boards govern the practice of medicine. Therefore, a board-certified doctor can determine how to use a particular drug.

“To be very, very clear, the FDA has no ability—zero ability—to have any control over how a physician practices,” said Bradford Adatto, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. “They are not in the business of regulating physicians. If you as a physician want to do something that’s off-label, it doesn’t affect you at all.”

In fact, off-label use has led to medical breakthroughs in the past. Aspirin, for example, was originally specified only to treat headaches—after it was introduced, doctors discovered that it thins the blood, and they began using it to treat heart congestion. (It has since been specified by the FDA for use in heart patients.) In the medical aesthetic industry, doctors have been known to try to use fillers and Botox in innovative ways to try to solve unusual problems presented to them by patients.

Regulatory Issues

Should patients and medical spa staff members worry about their doctor conducting off-label treatment? Generally, the answer is no, as it is up to the doctor’s judgment, and one can reasonably assume that judgment is informed by thoughtful research and years of experience.

“The physician has the ability to treat the patients based on their own medical knowledge, what other peers are doing, what is documented in medical journals that are out there or experiments they’ve done,” Adatto said.

However, doctors also have been known to use drugs on patients for more experimental purposes, and when that happens, state medical boards can intervene.

“If I, as a physician, am doing something that no one else is doing, and my medical board wouldn’t approve of it—there’s no medical journals on it, and I’m way off the skis of where everybody else is going, and I am just sailing in a direction where I’m all by myself—I could then be in trouble with my medical board for experimental use that’s outside the community of care of that particular specialty,” Adatto said. “You don’t want to be going in a situation where a medical board does not approve of that or believes it is too experimental or is not within the typical standard of care for a patient.”

If a physician is found to be using pharmaceuticals irresponsibly, he or she could be censured by the medical board and lose his or her medical license. In addition, he or she will need to explain his or her actions to the board.

Reckless Endangerment

In addition to facing sanctions from his or her state’s medical board, a physician who engages in reckless off-label drug use may be subject to legal liability issues. If a physician is found to have harmed a patient with his or her off-label pharmaceutical treatments, he or she could be sued for malpractice. If the off-label use resulted in serious injury death, a doctor can even be subject to criminal prosecution.

You may remember the case of Dr. Conrad Murray, the personal physician for music legend Michael Jackson. Murray was found complicit in the Jackson’s death because he improperly administered propofol—a drug specified for use as an anesthetic—in order to help the “King of Pop” sleep. He was found guilty of involuntary manslaughter and sentenced to four years in prison.

“Those drugs are usually only used for surgery, but there are other physicians who have used it to help calm individuals,” Adatto said. “It just then goes back to, not that many doctors were using it—it was a very small community that was using it—hence the malpractice, and then the liability of jeopardizing your license for being so far off-label.”

A doctor who is administering pharmaceuticals off-label also must be completely forthcoming with the patients being treated and obtain their express consent prior to providing these treatments. Misleading patients as to the specified use of the drugs being administered is another excellent way for a doctor to attract the attention of a state medical board.

“If you’re saying that this drug has been approved for this, and the medical board considers that what you’re providing is false or misleading information, that’s another potential issue,” Adatto said. “When you’re treating a patient on the front end, you must get that consent in order and make sure that the patient understands that the drug has not been approved for this type of use.”

In order to prove he or she has properly acquired consent for these treatments, the physician should be sure to get it in writing.

“We would always recommend to physicians that if you are going to be using a drug often for off-label, make sure you have a written consent that then describes that, so that a patient can also sign off on it, knowing that they received it both orally and in writing,” Adatto said. “That’s going to protect the physician, showing that they did tell this particular patient that they were using this drug for an off-label use, and the patient understood that and assumed some of those risks.”

Sensible Solutions

Off-label use can be a particularly tricky issue in medical spas, since non-doctors are sometimes the ones administering these treatments. Everyone in a medical aesthetic practice must understand that off-label use is a medical decision that is to be made only by a doctor. For example, a nurse administering an off-label pharmaceutical must be following a doctor’s order, and the decision needs to be established following proper delegation protocols.

If a doctor uses good judgment backed by research and is forthcoming with patients about why he or she wants to administer that drug in a manner that is not directly approved by the FDA, off-label use should result in no legal issues. However, obtaining patient consent is vitally important in cases such as these, so doctors should consult with their healthcare attorneys to verify that the consent they obtain will shield them from potential action.

In many cases, doctors who provide off-label treatments are simply attempting to help their patients. Providing them the leeway to do so has led to important medical breakthroughs and changed countless lives for the better. As long as doctors take the proper precautions, off-label use is perfectly acceptable from a legal standpoint.

Tags:  Med Spa Law  Med Spa Trends 

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How Core Doctors Can Cash In on Medical Spas

Posted By Administration, Wednesday, May 15, 2019

core doctors

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

The medical aesthetic industry continues to boom, and core doctors—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and cosmetic dermatologists—would seem to be set to profit in this space. As physicians, they are allowed to own medical spas, and they can ideally not only profit from the medical spas themselves, but also use them to direct business to their surgical practices. After all, medical spas tend to offer non-invasive procedures that are similar to some things core doctors do, and it does stand to reason that if patients go to a medical spa looking for a Botox injection, they might eventually want a nose job or a face-lift. That being the case, the core doctor who owns the medical spa should be uniquely positioned to offer his or her services.

However, that’s not necessarily the case. I chat with core doctors all the time, and those who open medical spas intending to use them primarily as feeders for their practices tend to view them as poor investments. Their medical spas tend to fail, and the amount of business they drive to their surgical practices is insignificant.

In truth, medical spas that are designed primarily to act as feeders for surgical practices are set up to fail, and most core doctors tend to be very bad medical spa owners. They typically don’t understand the medical spa business, how much work it takes, the profit margins, the necessary volume, and numerous other factors vital to maintaining a successful medical spa. But that doesn’t mean that a medical spa can’t still be a successful business for a core doctor or help to generate surgical business—it simply means that a core doctor needs to understand the realities of the medical spa industry before he or she decides to dive headlong into it.

A Singular Paradigm

The business model core doctors typically understand is very different from the one under which medical spas operate. Surgical practices offer big-ticket procedures, such as breast augmentations and face-lifts; they do not need to deal with a large volume of patients, and they do not need to market themselves like a retail outlet—by the nature of their business, they tend to generate sufficient revenue to get by.

While medical spas must follow the same rules and regulations to which more traditional medical facilities adhere, they are unique in that their services are entirely elective and entirely cash-based. People who use medical spas do so because they want to, and treatments at medical spas are much less expensive than those available from core doctors’ surgical practices. Therefore, for a medical spa to succeed, it must have a lot of patients, its employees must master the art of selling, and it must entice patients to return. In other words, it must operate like a retail center rather than a medical office.

For this reason, medical spas need to be run with a totally different mind-set than core doctors are typically used to. Medical spas owned by core doctors who do not adapt to a more retail-oriented emphasis often end up failing. When I tell core doctors that I have medical spa clients who generate up to $6 million annually, many of them cannot wrap their minds around how that is possible.

A New Perspective

In order for a medical spa to create business for a surgical practice, it must first succeed on its own terms. To facilitate that, core doctors typically need to let others run their medical spas. Core doctors need to understand that the medical spa business is much, much different than the ones they are used to, and they need to partner with people who are experienced with marketing and sales in a retail environment.

A core doctor’s time is better spent performing highly profitable surgical procedures, which medical spas cannot do. If a core doctor can get an experienced businessperson to operate the med spa, they will have a much better chance to succeed. Giving up this control can be difficult for core doctors, since a lifetime of academic and financial success tends to make them think they can achieve anything. However, most doctors don’t go to business school—they don’t know retail and they don’t understand sales. These qualities—rather than medical knowledge or surgical skill—tend to lead to medical spa success.

In addition, medical spa team members must be provided the tools and processes to sell. A medical spa receptionist, for example, should not be someone being paid $12 an hour with no experience; he or she should be one of the highest-paid people on an administrative staff, because he or she needs to be able to sell.

A medical spa also should provide talk tracks for nurses and aestheticians so they understand that their jobs are about selling themselves and the doctor. Employees at medical spas also need to understand that selling retail products is extremely important to maintaining a healthy business. These characteristics of successful medical spas may seem distasteful to doctors, who are used to professional environments that are less aggressive, but this is the reality of the medical spa industry, and every day more and more physicians discover this to be true.

The businesspeople who enter the medical spa industry are willing to do whatever it takes to be successful. A core doctor might believe he or she doesn’t need the help, but chances are the opposite is true.

There are several resources in the AmSpa store to help you build your business and train your team to put your medical spa practice in an excellent position to succeed.

The Practice of Medicine

A medical aesthetic practice must be focused on sales, but it also is required to follow the medical rules and regulations of the state in which it is located. These laws can vary significantly depending on the state, so a med spa operator should consult an attorney familiar with the industry when setting up the practice and procedures. AmSpa members can check their state’s medical aesthetic legal summary to learn about the rules and regulations governing their practice.

Most states observe a doctrine known as the corporate practice of medicine, which decrees that a medical practice must be owned by a physician or a physician-owned corporation. As previously established, medical spas are retail outlets, but they also are unquestionably medical practices, so medical spas must be entirely owned by a doctor or his or her corporation in states where the corporate practice of medicine is observed.

This can present problems for a core doctor who wishes to partner with a businessperson to run a medical spa, because the businessperson likely is going to want some equity in the practice. However, giving any ownership stake to a non-physician is illegal if the state where the medical spa is located observes the corporate practice of medicine.

Opportunities for Ownership

There are solutions, however. If a core doctor wishes to partner with an entrepreneur to open a medical spa in a corporate-practice-of-medicine state, he or she can set up a management services organization (MSO). An MSO provides practice management services, while the doctor, for whom a separate company is created, exclusively provides medical services.

This arrangement, known as a management service agreement (MSA), allows the non-physician who owns and/or operates the MSO to supervise almost every aspect of a medical aesthetic business, including branding, marketing, owning the real estate, payroll, human resources, accounting and billing—everything except the administration of medical services.

This is akin to a lessor/lessee situation. Generally, the MSO owns and maintains the facility, while the doctor inhabits the space. The doctor pays the MSO for the right to occupy the space, and the MSO acts as a landlord, maintaining the facility and keeping the doctor as comfortable as possible.

However, unlike a rental agreement that is managed by a lease that dictates the occupant pay a set amount of money for a certain term, the amount paid to the MSO fluctuates according to the amount of money the physician is paid by patients. If the medical organization treats more patients in a term than it did the previous term, the MSO will also make more money. This represents a sort of equity—in function, if not form. Read more about MSOs here.

The corporate practice of medicine also dictates the ways medical spa employees can be incentivized. In retail, salespeople are often offered commission—a percentage of the sales they make that meet certain conditions set by their employers. However, under the corporate practice of medicine, all payments for medical services must be made in full to a physician or physician-owned corporation. In these states, if a medical spa owner pays employees commission, he or she is engaging in fee-splitting, which is illegal.

This is somewhat common at medical spas. The people who own and operate these establishments generally only wish to reward the people who bring business to the practice, but if a medical spa is found to have engaged in fee-splitting in a state where it is illegal, the doctor who owns the practice could face the suspension or revocation of his or her license, as well as a significant fine. Additionally, the provider who receives the commission payment is subject to a fine. A performance-based bonus structure should be offered instead of commission. Read more about med spa compensation here.

Medical spa owners and operators who need to learn about the ownership requirements in their states should contact an experienced health care attorney to find out what is legal in their state.

Becoming a medical director for an existing medical spa, rather than opening a new practice, is another option for a core doctor. Several core doctors I have represented are doing this very successfully. They don’t need to deal with actual day-to-day operation of a retail store—they can simply lend their name to a medical spa, perform some consultations, oversee the practice’s other medical professionals, and then head back to their own practice rather than worrying about the intricacies of the business. This offers a core doctor a look at the industry without requiring him or her to make an enormous ownership commitment. It’s important, however, to understand the risks and responsibilities of med spa medical directors before committing to this course of action.

A Path to Success

The core doctors who oversee a compliant, well-run medical spa stand to gain a great deal from the arrangement. A successful medical aesthetic practice can earn a lot of money by itself, and if a med spa has a lot of patients, it makes sense that the number of referrals to an affiliated surgical practice will be higher than if it is struggling.

If a core doctor wants to enter the medical aesthetic industry, he or she cannot do it halfway. A medical spa that is created to function primarily as a compliment to a surgical practice is unlikely to find a great deal of success; one that is designed to succeed on its own terms, however, offers numerous benefits to its owners, including the possibility of increased surgical business.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn the legal and business best-practices you can employ to build and run a successful medical spa practice.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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