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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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Forest Park Verdicts Reshape Health Care Compliance in Texas

Posted By Administration, Tuesday, May 14, 2019

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By Jay Reyero, JD, Partner, ByrdAdatto

After years of anticipation, seven guilty verdicts in the Forest Park Medical Center criminal trial—in addition to the 10 pre-trial guilty pleas—have reshaped the health care landscape in Texas, and the nation is watching. While the exact fallout from the stunning conclusion will take some time to play out (appeals will be filed), there are two immediate takeaways of how health care compliance has permanently been impacted.

The federal government’s use of the Travel Act, a federal law criminalizing business activities that are illegal on the state level, was one of the most closely watched elements of the Forest Park case. While originally geared towards organized crime, prosecutors in the Forest Park case used the Travel Act in the health care context to target a physician kickback scheme where federal programs were not involved. The most interesting but unresolved issue is exactly how successful, if at all, the Travel Act can be in health care enforcement efforts in Texas. Unlike the federal government’s success in New Jersey, the verdicts in Forest Park reveal the Travel Act was not expressly relied upon by the jury to convict the physicians involved.

Nevertheless, Forest Park demonstrates that the Travel Act is a very real and controversial enforcement tool the federal government believes can be successful and is willing to use to combat fraud and abuse. Based on this new federal strategy, health care arrangements in Texas must include a risk assessment of the application of the Travel Act. We would recommend this risk assessment even when no funds from federal programs are involved. The possibility of the federal government’s involvement naturally increases risk and the specter of scrutiny. Anyone involved in a health care arrangement should take immediate steps to reevaluate the arrangement, taking into account this heightened level of risk.

The importance placed on the intent of the parties involved is another aspect of the Forest Park case that was illuminating. At the center of the case were marketing agreements developed with the assistance of qualified health care counsel, which on their face appeared to be bona fide arrangements. More importantly, the agreements were developed and appeared to be structured in compliance with applicable kickback regulations. However, throughout trial, the federal government pressed that the parties intended to induce referrals, despite what the terms of the marketing agreement indicated. The Forest Park case reinforces a critical understanding in health care compliance that form must equal substance. Even when parties attempt to structure arrangements within the requirements of applicable rules and regulations, the underlying intent must be aligned, as any deviation can give rise to significant issues regardless of the form. As evidenced by the Forest Park case and the testimony supplied by many of those involved in the scheme who had already pled guilty, the greatest risk of exposing the truth behind the intent of the parties of any arrangement is those individuals involved in the arrangement. Therefore, anyone involved in a health care arrangement should examine the circumstances beyond the document and ensure the intent and actions of all involved are consistent with compliance expectations.

The Forest Park case is a signal that a bigger and brighter spotlight is now shining on the health care industry in Texas from a fraud and abuse perspective. Gone are the days when one could be comfortable with the historical inaction of the Texas government in kickback enforcement efforts, as now the federal government has a powerful new tool that allows it to step in to enforce state laws. Even if the Travel Act is not successful on the technical merits, the Forest Park case is a clear signal the federal government can still use it to get in the door to obtain criminal indictments and potentially lead to convictions. With the use—and possible success—of the Travel Act, all health care arrangements in Texas, regardless of which payors are involved, are facing a heightened level of scrutiny. Every provider in the state should be reevaluating their arrangements from a regulatory compliance risk perspective.

Jay Reyero, JD, is a partner at the business, healthcare, and aesthetic law firm of ByrdAdatto. He has a background as both a litigator and transactional attorney, bringing a unique and balanced perspective to the firm’s clients. His health care and regulatory expertise involves the counseling and advising of physicians, physician groups, other medical service providers and non-professionals. Specific areas of expertise include federal and state health care regulations and how they impact investments, transactions and various contractual arrangements, particularly in the areas of federal and state anti-referral, anti-kickback and HIPAA compliance.

Tags:  ByrdAdatto  Med Spa Law 

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Florida Office Surgery Reforms Pass House and Senate

Posted By Administration, Thursday, May 9, 2019

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

A recent news article features shocking reports of patient injury and death at dishonest Florida plastic surgery clinics. These stories are heartbreaking to read. They include young children losing their mother, mothers losing their daughters, and people forced to live with pain and disfigurement because of complications from improperly performed procedures. The article calls out several clinics as being repeat offenders. To be sure, the vast majority of surgery clinics are run safely and ethically, but the clinics mentioned in the article are egregious examples of a malfunctioning oversight system.

Over the past two decades, Florida has become a mecca for plastic surgery, and many procedures there are performed in office settings outside of licensed hospitals or ambulatory surgery centers. To monitor and regulate these offices, Florida requires that all physicians register the offices where they perform complex procedures.

The current Florida office surgery registration rules divide procedures into three levels, based on their invasiveness and the type of anesthesia used. Level I procedures have a low risk of complication and require only local or topical anesthesia; these are procedures such as minor excisions of skin tissues or liposuction of less than 4,000 ccs of supernatant fat. Level II procedures use medication that can require conscious sedation and can include deeper tissue biopsies and hernia repair. Level III procedures require general anesthesia or greater sedation than Level II procedures.

Florida requires that all physicians register the offices where they perform Level II procedures that last longer than five minutes or any Level III procedure. Registered offices must undergo an annual scheduled inspection, meet certain standards, and report adverse incidents to the Department of Health within 15 days.

While current rules provide for some oversight of these offices, the enforcement mechanisms can be slow to implement and take effect, as evidenced by the linked article. In response to these gaps, lawmakers have introduced legislation that is designed to strengthen the process. The bills, known as House Bill 933 (HB 933) and Senate Bill 732 (SB 732), would expand the registration requirement to more offices and provide stiffer penalties and stronger enforcement for violations. In their current forms, both bills would require offices to register if they perform any Level II or III procedures, or if they perform liposuction of more than 1,000 ccs of supernatant fat, which is broader than the current rules. Additionally, the bills would allow the board to suspend or revoke an office’s registration or a licensee’s ability to operate, as well as impose penalties if they are discovered to not be in compliance with regulations. Legislators hope that this will give the board the tools to crack down on the types of unsafe operations described in the article and to prevent unsafe owners or physicians from switching offices to avoid detection.

Past efforts to increase regulation and enforcement for these types of clinics have failed to gain passage, typically getting stuck in committee. However, this year’s efforts appear to have been successful. SB 732 has received favorable votes from each committee and just last week passed the full vote of the Senate, from there it headed to the House. On May 1st, SB 732 unanimously passed the House vote. Now SB 732 heads to the governor’s desk for signature. Once signed, the provisions of SB 732 become effective January 1, 2020.

As is often the case with legislation like this, the burden and costs of compliance will fall most heavily on offices that already are safe and well run—they will need to update their policies and procedures and come into compliance with the new rules. If you believe your practice may be affected by these new rules or have questions about staying in compliance, contact AmSpa or ByrdAdatto.

Tags:  Med Spa Law 

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