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Join AmSpa at the Orlando Medical Spa & Aesthetic Boot Camp

Posted By Administration, Friday, October 25, 2019

caribe royale orlando

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

Starting next Saturday, November 2, AmSpa will host its Orlando Medical Spa & Aesthetic Boot Camp at Caribe Royale Orlando. This is the last AmSpa Boot Camp until April 2020, so if you are a medical aesthetic professional who wants to learn how to improve your practice, make your plans to join us next weekend. There’s still time to register for the event—just click here to sign up.

Here is a quick overview of the program:

Saturday, November 2

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.
  • 10:45 – 11:45 a.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.
  • 12:45 – 1:30 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), Candace Noonan (Environ Skincare) and Gail Winneshiek (Galderma)—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Bradford Adatto (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.
  • 4:15 – 5 p.m.: The Treatments, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and find out how to best determine which treatments are right for you based on the state of your practice.
  • 5 – 6 p.m.: The Digital Marketing Ecosystem, presented by Tim Sawyer (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.

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

Sunday, November 3

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 Long-term Revenue, presented by Brandon and Jenny Robinson (Skin Body Soul)—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.
  • 11:30 a.m. – 12:15 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 – 2 p.m.: The Marketing Plan and Social Media, presented by Brandon and Jenny Robinson (Skin Body Soul)—This session will help you determine how to most effectively market your medical aesthetic practice using both traditional methods and cutting-edge techniques.
  • 2 – 3 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.

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

We hope you can join us in Orlando next weekend. This Boot Camp is a tremendous opportunity to get a medical aesthetic business started off on the right foot, and learn how to take an already successful business 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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How the Update to the Texas Privacy Breach Notification Law Could Affect Your Medical Spa

Posted By Administration, Friday, October 11, 2019

data breach

By Jay Reyero, JD, Partner, ByrdAdatto

Target. Equifax. Facebook. Capital One. For us, a data breach is a reminder that the sensitive information we routinely entrust to organizations has inherent value and can be subject to nefarious attacks. For organizations, it is a reminder of the great responsibility accepted because of the great power received from valuable information. For states across the country, it is a reminder that more needs to be done in the fight for privacy and protection of sensitive information. With the passage of House Bill 4390 (HB 4390), Texas has showed how it plans to address the privacy of personal identifying information.

Signed into law on June 14, 2019, HB 4390 amends Texas’s privacy breach notification law—Texas Business and Commerce Code Chapter 521, Identity Theft Enforcement and Protection Act—by specifying a time frame for when notice of a breach is required and creating a notification requirement to state regulators. Beginning January 1, 2020, if a breach occurs and disclosure is required, the disclosure must be made “without unreasonable delay and in each case not later than the 60th day after the date on which the person determines that the breach occurred.” Previously, the disclosure only needed to be made “as quickly as possible.”

It is important to understand that the 60-day time frame doesn’t create a window for compliance, so organizations should not feel comfortable simply getting disclosures out by the 60th day to comply. Instead, organizations are first responsible to provide disclosure “without unreasonable delay,” which, depending on the circumstances, could be well short of the 60 days. If the circumstances support a reasonable delay approaching 60 days, an organization will then need to ensure that disclosure is provided before the deadline.

Also, beginning January 1, 2020, HB 4390 requires notification to the attorney general for breaches involving at least 250 Texas residents. The notice will need to include:

  1. A detailed description of the breach;
  2. The number of residents affected;
  3. The current and planned mitigation efforts; and
  4. Any law enforcement involvement.

All organizations subject to Texas’s breach notification law should begin reviewing and updating their breach notification policies in preparation for the new rules in 2020.

In addition to the current changes to the Texas privacy breach notification law, HB 4390 signals that Texas is not done addressing privacy with the creation of the Texas Privacy Protection Advisory Council. The purpose of the council will be to study various privacy laws and make recommendations to the Texas legislature on specific changes regarding privacy and protection of sensitive information.

To learn more 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 become the next med spa success story.

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

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Medical Spa Buzzwords

Posted By Administration, Friday, October 4, 2019

wellness

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

The medical aesthetic industry is all about buzz. A treatment that’s hot one day can be passé the next, and keeping tuned into the buzz around the industry is the only way to keep track of what’s what. There are a few terms that you’re likely to come across again and again, however, and understanding why people are talking about them is a key to maintaining a successful practice. Here are a handful of the buzzwords we’re encountering regularly, what you need to know about them, and how you can harness their power.

Wellness

Historically, medical aesthetics have been associated with fast, easy solutions rather than lasting change, but, in recent years, the mantra of wellness has become a key part of the industry. Today, it’s not enough to simply look good; you must also be healthy, so a holistic approach to self-care has become a part of many aesthetic regimens.

Wellness is a concept that informs many of the other terms we’re going to cover here. Generally speaking, there is a bit of a stigma attached to “quick-fix” solutions for aesthetic issues, so many practices have begun offering more natural, organic solutions and encouraging more comprehensive views of patients’ overall health. After all, no medical spa wants to be featured as part of an exposé on botched aesthetic procedures, and the chances of that increase if your practice uses a lot of harsh chemicals and complicated treatments.

What’s more, a healthy body helps contribute to a healthy mind, and those with healthy minds are less likely to cause problems for your medical spa with unfair expectations and difficult-to-address social media reviews.

Rejuvenation

The concept of rejuvenation is a powerful one for medical aesthetic practices, as it suggests that those who partake of aesthetic treatments can recapture aspects of their youth they thought were gone forever. This is a powerful impression, and successful medical spas are able to leverage it to attract customers who are not entirely happy with their appearance or physical health.

Of course, this term is also now commonly associated with vaginal rejuvenation, a very popular treatment that has attracted a lot of attention to the medical aesthetic industry in recent years, particularly after the commissioner of the U.S. Food and Drug Administration (FDA) issued a statement in October 2018 addressing the use of unapproved laser equipment for the procedure. Despite this warning, the market for this treatment continues to be robust.

Anti-aging

This is a loaded term. Obviously, everyone is subject to aging—after all, we all do it every minute of every day. However, medical aesthetic practices, drug manufacturers and device manufacturers use this term to insinuate that their offerings can be used to combat this process, and the suggestion that such a thing is possible is an extremely attractive proposition for those who don’t like what they see in the mirror.

Realistically, though, this term only covers the signs of aging, so it’s a bit misleading when employed as it commonly is. It remains a powerful buzzword in the medical aesthetic industry, however, and as the wealthy Boomer population continues to age, it’s going to keep bringing business through medical spas’ doors.

Preventive

As the old saying goes, an ounce of prevention is worth a pound of cure. This buzzword suggests to prospective customers that the medical aesthetic treatment being advertised can help thwart future problems. Again, this is an attractive concept, both for patients who are conscientious about their appearance and for practices that stand to make money from said patients for treatments they don’t immediately need. That’s not to say that these treatments aren’t useful—to the contrary, they provide tangible benefits over time and a are part of a well-rounded aesthetic care regimen. Over time, it’s more beneficial and cheaper for patients to engage in preventive care instead of waiting for problems to emerge.

Along the same lines, prevention is a key concept when it comes to medical spa legal compliance. It is significantly less expensive to implement proper protocols and procedures at the beginning of a medical aesthetic practice’s existence than it is to correct issues after they are uncovered by a regulatory agency. It’s also a good idea to get into the habit of compliance as soon as possible, since it is a significant part of a practice’s existence.

Non-invasive

The term “non-invasive” gets to the heart of the appeal of the medical aesthetic industry. The treatments provided to medical spa patients produce visible, often lasting results without the need for painful, expensive surgeries that require prolonged periods of recovery. The term also suggests a certain convenience—medical aesthetic treatments are non-invasive in terms of the amount of time spent at the practice, as well. A patient can typically pop into a med spa, receive a treatment, and continue on with his or her day.

Although plastic surgeons have historically been key parts of the medical aesthetic industry, the non-invasive nature of medical spa treatments typically makes them much more appealing than surgery to the average consumer. As such, practices likely will benefit from using this term in their marketing materials.

Detoxify

Nobody wants toxic things on or inside them, obviously, so the promise of removing these harmful elements is extremely appealing. As a result, the term “detoxify” is widely used in the medical aesthetic industry, and is effective at convincing people to undergo treatments provided by medical spas. Along the same lines, the term “cleanse” helps patients see that these treatments can help them become healthier and remove detrimental influences on their bodies. From a psychological standpoint, these are extremely powerful suggestions, and they can (and should) also be reflected in a medical spa’s design and layout—a practice should always be clean and inviting, so as to reinforce that it is a place where such things are valued. In maintaining your practice properly, you tell your clients that you are serious about all aspects of wellness.

Restore

If you tell a patient that you’re going to restore their appearance, you’re telling them that you can bring back something they thought they’d lost. Again, this is a powerful idea, and that’s why the term is so widely used in the industry. If you can restore the way a person looked in the past, perhaps you can restore the way they felt back then, as well—or at least that’s the implication. It speaks to the power of medical aesthetic treatments and helps to attract new customers to medical spas.

Youth

Again, the use of terms such as “youth,” “young” and “younger” reflects a desire on the part of medical spa patients to recover some of the vitality they’ve lost over the years. This is particularly true for Baby Boomers, who have the money to spend on procedures such as these and the time to become active again, since many are nearing or entering their retirement years. During this time in their lives, people encounter numerous milestones that suggest to them that their best years are behind them, and many are taking steps to combat that sentiment. Because of this, boomers are helping to drive the medical aesthetic industry revenues, and tapping into their desire to feel young again can help your practice develop new customers.

Repair

People want to believe that damage can be repaired. If you wreck your car, you keep telling yourself that it’s not that bad and that it can be fixed—at least until the mechanic tells you that it’s totaled. That sort of optimism can also be leveraged in medical aesthetics, even if the “damage” isn’t particularly severe. (Severe damage will probably require the skills of a plastic surgeon.) This term can be used to promote procedures such as tattoo removal and microdermabrasion, as well as a number of more conventional aesthetic treatments.

Market the Buzz

Language is a powerful tool in marketing, and learning how to leverage buzzwords such as these will help you maximize your medical aesthetic practice’s business. As you can see, a lot of this amounts to offering clients idealized versions of themselves, and as long as you can provide them a means to do that once you get them in the door, your practice stands to benefit from their patronage. Using these terms taps into people’s desires to recapture—or prolong—their glory days and to look as good as they feel, and this is something that medical spas can provide quickly, conveniently, and generally without complications. Understand who you are marketing to and what they want, and you’ll find yourself with a thriving medical aesthetic practice.

To learn more 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 become the next med spa success story.

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

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Join AmSpa at the New York Medical Spa & Aesthetic Boot Camp

Posted By Administration, Wednesday, October 2, 2019

new yorker hotel

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

Starting next Saturday, October 12, AmSpa will host its New York Medical Spa & Aesthetic Boot Camp at The New Yorker Hotel (A Wyndham Hotel). We’re extremely excited for the opportunity to help medical aesthetic professionals in the Big Apple improve their practices, and we’re looking forward to visiting New York once again. There’s still time to register for the event—just click here to sign up.

Here is a quick overview of the program:

Saturday, October 12

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 – 10:00 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.
  • 10:15 – 11:15 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.
  • 11:15 a.m. – 12:15 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.
  • 1 – 1:45 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), Toni Lee Roldan-Ortiz (Environ Skincare), and a representative from Galderma—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:45 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Renee 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.
  • 4:15 – 5 p.m.: The Treatments, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and find out how to best determine which treatments are right for you based on the state of your practice.
  • 5 – 6 p.m.: The Digital Marketing Ecosystem, presented by Tim Sawyer (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.

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

Sunday, October 13

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 – 9:45 a.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.
  • 10:30 a.m. – 11:30 p.m.: The Medical Spa Success Panel, featuring Alexander L. Blinski, MD, (Plump), Marria Pooya (Greenwich Medical Spa), and Alexa Nicholls Costa, NP, and Alexandra Rogers, NP (LexRx)—This exclusive panel features four of the most successful aesthetics professionals in the Northeast. I will ask them how about the innovative business strategies and techniques they used to rise to the top of the medical aesthetic industry.
  • 11:30 a.m. – 12:15 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 – 2 p.m.: The Marketing Plan and Social Media, presented by Alexa Nicholls Costa, NP, and Alexandra Rogers, NP (LexRx)—This session will help you determine how to most effectively market your medical aesthetic practice using both traditional methods and cutting-edge techniques.
  • 2 – 3 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.

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

We hope you can join us in New York next weekend. This Boot Camp is a tremendous opportunity to get a medical aesthetic business started off on the right foot, and learn how to take an already successful business to the next level. Click here to register!

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

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How Your Medical Spa Can Address Negative Patient Reviews

Posted By Administration, Monday, September 30, 2019

one star

By Kita McCray, JD, ByrdAdatto

Benjamin Franklin said, “It takes many good deeds to build a good reputation, and only one bad one to lose it.” It’s been a couple of centuries since Franklin made this statement, yet the same remains true today. It is especially true in health care, where patient dissatisfaction can be amplified with just a few keystrokes and the click of a mouse.

On one hand, the internet has expanded our accessibility to one another and information; on the other hand, it provides a medium for bad reviews and feedback to travel further and faster than our reputations can keep up with. As a result, many patients think they “know” their providers before they ever meet them. So, what’s the solution when that one dissatisfied patient tries to start a fire by posting a negative review of you or your practice? The answer is simple: Dilute the fire—the solution to pollution is dilution.

Jeff Segal, MD, JD, a ByrdAdatto partner and CEO of Medical Justice, has built a simple strategy for dealing with negative patient reviews. Specifically, when writing a response to a negative patient review, you must remember these five golden rules:

  1. A model response shows the practice is reasonable and isn’t engaged in a debate;
  2. A model response educates the public;
  3. A model response addresses the concerns raised in the review;
  4. A model response takes the conversation offline; and
  5. A model response does not address the author directly.

Segal further advises that the person or employee who is responsible for locating and responding to negative reviews should commit to these rules in order to dilute or drown out the dissatisfied voices in the crowd. These rules also will help you to avoid potential violations of HIPAA or professional licensing board regulations that may cause regulators to perceive the filtering of negative reviews as false and deceptive advertising.

Remember that it takes two flints to make a fire. Engaging in a debate with a dissatisfied patient in a public way is a bottomless pit. Once you fall in, it can be difficult to pull your reputation out.

To learn more 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 become the next med spa success story.

Kita McCray’s decision to become a lawyer was solidified in fourth grade after job shadowing a local lawyer in her hometown of Ferriday, Louisiana. In college, Kita dedicated all her enthusiasm and energy to becoming well-read in classic English literature before attending law school. But while working as a public health graduate researcher, she developed an interest in health law and policy, and decided to focus her legal studies toward health care law.  Today, Kita brings the full scope of her multidisciplinary background to assist clients with their business and health care needs.

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

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Medical-grade Skin Care vs. OTC Skin Care: What’s the Difference?

Posted By Administration, Monday, September 23, 2019

skincare

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

As anyone who has to deal with chronic pain will tell you, there is a world of difference between prescription pain-relief drugs—such as oxycodone and hydrocodone—and over-the-counter (OTC) pain-relief drugs, such as ibuprofen. The U.S. Food and Drug Administration (FDA) categorizes these drugs according to their active ingredients. Hydrocodone, for example, is an opioid, and it has a significant effect on certain receptors in the body, while ibuprofen merely inhibits enzymes, which produces a much less intense reduction in pain. Of course, opioids can be highly addictive, so requiring a prescription also (theoretically) keeps them out of the hands of people who would abuse them.

FDA categorizes skin care products somewhat similarly, and medical aesthetic professionals should know why some products require prescriptions, while others are more widely available. Understanding the difference can not only help medical aesthetic practices provide better patient care, but may also affect their bottom lines.

Cosmetics vs. Drugs

The FDA addresses the use of drugs and cosmetics under the Federal Food, Drug, and Cosmetic Act, which was enacted in 1938 and has been amended numerous times since then. The text of this act draws a distinction between “cosmetics” and “drugs” that provides relatively definitive guidance on this topic. A cosmetic is defined as a product that is “intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Obviously, many products that are commonly used in medical spas and medical aesthetics fall under this category.

Drugs, meanwhile, are “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the legal difference between a cosmetic skin care product and a skin care drug is the product’s intended use.

“If you say you're going to eliminate fine lines and wrinkles, that claim—which alters the form and function and structure of the body—is a medical claim and, therefore, that product is considered a drug by the FDA. It has to be approved and regulated, and there's a long process to get through,” explains Rob Trow, CEO of DermaConcepts, the exclusive U.S. distributor of Environ Skin Care. “If you say that the skin care product will improve the appearance or look of fine lines and wrinkles, that's not a medical claim, and therefore it's not a prescription product and can be sold without it.” Drugs must be approved by the FDA, while cosmetics do not need approval, so a few words in a product’s description can make an enormous difference for the manufacturer.

“If a product says [it] will produce collagen and elastin, that's a product that affects the form and function of the body and is a medical claim, and therefore the product should be classified as a drug and go through a very complex and costly approval process,” Trow says. “If you look at the ads for skin care, you'll see many, many ads make those claims, even though they're not allowed to. But most skin care companies qualify the claims with adjectives that talk about ‘the look of, the feel, the appearance of,’ rather than affecting the change.”

According to Carl Thornfeldt, MD, founder and CEO of Epionce: “Many cosmetic products claiming they are effective for treating skin disease are mislabeled, basically not complying with FDA regulations. Moreover, many have no safety or efficacy studies.”

The concentrations of certain chemicals and compounds in a product also can determine whether it is a cosmetic or a drug. For example, a product with a 2% concentration of hydroquinone is considered cosmetic, while one with a 4% concentration is considered a prescription drug.

“[Some] medical skin care products—the technologies that proved themselves in performance and safety—may later move toward implementation in OTC products. [These would be] potentially less concentrated ones, but utilize proven clinical technology,” says Nikolay Turovets, PhD, CEO for DefenAge Skincare. “The most famous example, of course, are retinols.”

Some cosmetic manufacturers choose to submit their products for FDA approval and create their products according to FDA regulations, but they are not required to do so.

“There are certain cosmetic companies that have their own factory, that manufacture in clean rooms with nitrogen blankets, red and yellow light, pressurize the air system, and it's like going into an operating room where everybody is gowned and booted,” Trow says. “Some cosmetic companies use airless pumps, because if you let air and light into a product, you destroy its efficacy. So there are non-prescription products that are manufactured as stringently as prescription drugs. Unfortunately that has nothing to do with requirements by law, but rather the values and the investment in that process by the specific skin care company.”

Degrees of Drugs

If a skin care product is categorized as a drug, it falls into one of two categories: OTC or prescription. OTC drugs are typically available to anyone who wants to purchase them, although the sales of a small number of OTC products are restricted to a degree due to their active ingredients. (Pseudoephedrine, for example, is kept behind drugstore counters because its active ingredient is commonly used in the illicit manufacture of methamphetamines.) Only a few types of skin care products fall into the OTC drug category; typically, they are sunscreens and other general skincare products.

“There are many great product lines available in retail stores over the counter,” says Barbara Pestana, director, U.S. medical sales and marketing for NeoStrata Company, Inc. “OTC products can support general skin care needs, such as cleansing, hydration and sun protection.” Although OTC products are not as heavily regulated as prescription drugs, they still are held to high standards.

“OTC drugs must use pharmaceutical-grade [ingredients] and be manufactured in an FDA-inspected, [good manufacturing practice]-compliant facility,” explains Thornfeldt, whose company manufactures a number of OTC skin care products. “OTC drugs must also comply with FDA over-the-counter-drug monographs for the chemicals themselves, the concentration ranges, and the rules regarding claims for disease or conditions the active ingredient treats.”

It is not impossible for a drug to go from prescription to OTC, though it is not terribly common. Widely used drugs, such as cetirizine (Zyrtec), fexofenadine (Allegra), famotidine (Pepcid) and omeprazole (Prilosec) have made the switch, as have a handful of smoking-cessation aids and hair-growth products. Even ibuprofen was formerly only available via prescription.

“Pretty often, the most innovative, groundbreaking and revolutionary technologies are initially offered to market through medical distribution channels,” says Turovets. “For example, almost 20 years ago, when Dr. [Richard] Fitzpatrick introduced SkinMedica to the market, it was mind-blowing innovation—use of growth factors produced by living human cells in a laboratory to stimulate skin.”

However, while OTC products can be used without supervision, there are a number of advantages for patients who consult with physicians to develop a course of skin care treatment, including the use of prescription products.

“These products are often sold and recommended by a medical professional who will examine and diagnose skin care needs and create a targeted program to help patients achieve their goals,” Pestana says. “The program will likely include in-office devices and peels, along with a customized home-care regimen to enhance the effects of the procedures. Medical-grade skin care often provides protocols for both in-office procedures and home care that can be personalized to the needs of each patient.”

Expanding Understanding

Operators of medical spas and medical aesthetic practices should have a good understanding of the products that are being used in their practices and work with patients to fully understand their current OTC or prescription skin care regimens and how they can be adapted to bring about the best possible result for the 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 become the next med spa success story.

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

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New York Nursing Board Says Microneedling Is the Practice of Acupuncture

Posted By Administration, Wednesday, September 18, 2019

microneedling

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

Over the last several years, microneedling has exploded in popularity, becoming a core procedure in medical spas. According to AmSpa’s 2019 Medical Spa State of the Industry Report, 84% of medical spas offer some form of microneedling. The majority of states consider microneedling that pierces the outer layer of skin—the stratum corneum—a medical procedure that must be performed by an appropriately trained person under the supervision of a physician or other independent licensed health care professional. But New York has taken the unusual position that microneedling is part of the practice of acupuncture.

The New York Board of Nursing has provided guidance that microneedling is not within the nursing scope of practice; however, the Board of Acupuncture confirmed that microneedling is within its license’s scope of practice. It is not unusual for a procedure to be within the scope of some nurse licenses but out of others based on the skill and training needed for the treatment, but it is unusual is that all levels of nurses are excluded from performing microneedling, regardless of training. Otherwise, nurses in New York are able to perform a broad range of services in a medical spa. For example, when registered nurses are acting under the authority of a valid provider, they may inject neuromodulators and fillers, fire both ablative and non-ablative lasers, use radio frequency devices, and provide skin peels and light treatments. However, they may not provide miconeedling unless they are separately licensed in acupuncture.

This is a somewhat unusual interpretation, as although the two techniques both employ needles to pierce the skin, their goals and methodology are entirely different. New York defines the “profession of acupuncture” to entail the insertion of needles or application of heat, pressure or electrical stimulation on a point of the body on the basis of the theory of physiological interrelationship of body organs with a point or points of the body. On the other hand, microneedling typically is the insertion of needles into the skin for the purpose of stimulating collagen production. While certain types of microneedling may use energy or injections to improve the procedure’s effect on the skin, its goal is only to improve the skin tissue to which the treatment is applied, while acupuncture is meant to improve or affect a different organ or portion of the body than the area treated. And while this interpretation is unusual, it is not unique. The Massachusetts Board of Registration in Nursing, in an advisory ruling, has similarly interpreted microneedling to be outside the scope of nursing; an acupuncturist license is required to perform the procedure in that state as well.

I do want to stress that this information all comes from informal correspondence with the nursing and acupuncture boards. There currently is no law, rule or official advisory opinion stating that nurses cannot perform microneedling and acupuncturists can, so carefully review your own practice situation before making any major changes. We will continue to attempt to get some clear guidance on this unusual interpretation. AmSpa members can check their state legal summary, or utilize their annual compliance consultation with the business, health care and aesthetic law firm of ByrdAdatto for more information on medical spa law.

If you live in New York and want more information on this and many other topics relevant to your medical spa, attend AmSpa’s New York Medical Spa & Aesthetic Boot Camp October 12 – 13 at The New Yorker Hotel (A Wyndham Hotel) in New York City. Click here to register today and become the next medical spa success story.

Tags:  AmSpa's 2019 Medical Spa Statistical Survey  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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Medical Board of California Issues Warning for Hair Restoration Technicians

Posted By Administration, Friday, September 13, 2019

hair restoration

By Michael Byrd, JD, partner, ByrdAdatto

The Medical Board of California (MBC) has warned physicians against using unlicensed persons for hair transplant procedures in the summer issue of its newsletter. (The issue is available here, with the article appearing on page 12.) It states that the MBC has become aware of many physicians or clinics that are employing trained but unlicensed persons, referred to as medical assistants (MAs), to perform or assist with hair transplant procedures. The article gives the example of MAs creating holes or slits in the patient’s scalp using a needle, scalpel or other device as being prohibited. While it does not explicitly state that this is the case, its warning would seem to apply equally to harvesting follicles as it would to preparing the follicle implantation sites.

In California, MAs have a very limited scope of tasks they are permitted to perform. They are permitted to perform only “basic administrative, clerical and technical supportive services,” with several procedures specifically authorized in 16 CCR § 1366. With the exception of puncturing skin or vein for purposes of drawing blood, their other authorized tasks are non-invasive and include tasks such as trimming nails and ear lavage. Likewise, the MBC has stated that MAs may not inject fillers, nor may they fire lasers. The article warns that physicians who violate this restriction are aiding the unlicensed practice of medicine, which can carry penalties of fines or imprisonment. If you are employing MAs in your practice, you will want to carefully review what tasks you are assigning to them and ensure that the delegations are legally permitted.

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 become the next med spa success story.

Michael S. Byrd is a partner at the law firm of ByrdAdatto, a national business and health care boutique law firm with offices in Dallas and Chicago. As the son of a doctor and entrepreneur, he has a personal connection to both business and medicine. He has blended these life experiences to become a leading advocate for doctors and dentists throughout the United States. He routinely lectures at continuing education seminars on the various business and legal issues that professionals face. Outside of health care, Michael has used these same skills to handle sensitive and complicated business matters for entrepreneurs, business owners, attorneys, CPAs, high-net-worth individuals and public figures. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2019), was named a Top Rated Lawyer by the Dallas Morning News (2016), and has been recognized as a Best Lawyer in Dallas in health care by D Magazine (2013, 2016-2019).

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

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How the Texas Corporate Practice of Medicine Relates to Medical Spa Ownership

Posted By Administration, Tuesday, September 10, 2019

medical law

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

Recently, AmSpa has been getting a lot of emails and calls telling us they have been informed that in Texas, unlicensed people can own a medical spa and simply hire a medical director. This contradicts our information, as well as ByrdAdatto’s research on the subject: Texas’ corporate practice of medicine (CPOM) policy generally prohibits non-physicians, lay corporations and other entities from employing a physician to practice medicine. We understand how there can be some confusion, as the various authority and elements that make up the legal basis for Texas’s CPOM policy are scattered in a number of places. However, we wanted to provide our Texas members with some additional information on this, because it is important to stay in compliance with the policy; failing to do so can open the physician up to discipline for abetting the unlicensed practice of medicine, and can subject the non-physician owners to fines and penalties as well. You only need to look to the Texas Medical Board’s June 27, 2019 press release for examples of the board taking action. In one instance, a physician was prohibited from performing, supervising or delegating medical spa procedures for five years for aiding the unlicensed practice of medicine and lending his license to a medical spa. In two other cases, unlicensed medical spa owners entered into agreed cease-and-desist orders with the board; they had been engaging in the unlicensed practice of medicine by advertising and providing medical cosmetic procedures. This article will explore some of the main sources of this policy and attempt to dispel some of the confusion.

A discussion of this topic should begin with the Texas Occupations Code Chapter 3 Subtitle B, collectively referred to as the “Medical Practice Act.” Section 155.001 requires that a person must hold a license to practice medicine. Section 155.003 make it clear that only a person who has completed the required educational steps may hold a license to practice medicine. Section 165.152 make it a violation subject to penalties for a person to practice medicine in violation of the Medical Practice Act. Section 165.156 also make it a violation for a “person, partnership, trust, association or corporation” to use any letters, words or terms in any manner that indicate it is licensed to practice medicine if it is not, in fact, licensed to practice medicine. In Section 164.052, the code states that a physician is subject to discipline if he or she “directly or indirectly aids or abets the practice of medicine by a person, partnership, association or corporation that is not licensed to practice medicine by the board.” Section 165.155 prohibits a physician from paying or rewarding any person or entity for soliciting or securing patients. Taken together, it is clear that an unlicensed person, corporation or other entity cannot advertise that they practice medicine or offer medical services, and they cannot simply hire a physician to lend a license to their business.

Now, there are a number of exceptions to this general prohibition on employing physicians. The Texas Medical Board has adopted Rule §177.17 and provided a FAQ article on CPOM that provides a helpful summary of the information and possible exemptions. Rule §177.17 lists various exempt hospitals, non-profits and institutions. However, those entities are not applicable to a privately owned medical spa. Corporations and other entities properly formed and owned under Title 7 (Professional Entities) of the Texas Business Organizations Code are also exempt. A properly owned professional medical corporation may hire physicians and offer medical services.

The Texas Medical Board’s FAQ also mentions that physicians may enter into an independent contractor relationship, though it is a question of law and facts whether it is a permitted independent contractor or a prohibited employment relationship. Under 151.055, hospitals may enter into independent contractor agreements with physicians. However, for other physician and non-physician relationships the navigation can be incredibly tricky. Any independent contractor arrangement must still comply fully with the Medical Practices Act, as well as not fall into any aspects that would make it a prohibited employment relationship. Each of the listed court cases and attorney general opinions addresses different aspects used in determining independent contractor status from employment relationships. Some of the issues examined are the flow of funds, setting of fees, ownership, control over medical decisions, control over services or employees, and advertising. This means that even if your agreement says “independent contractor,” it may still be a prohibited employer/employee relationship if it does not satisfy all these elements.

For example, in the case of F.W.B. Rockett v. Texas State Board of Medical Examiners, the physician saw patients and reviewed X-rays for a non-physician-owned clinic; for his services, he was paid a flat monthly fee. In this case, the physician lost his license because he was permitting an unlicensed person to practice medicine. Similarly, in Flynn Brothers, Inc. v. First Medical Associates, the physician claimed to be an independent contractor, but the court found him to be an employee because, among other reasons, the non-professional entity retained two thirds of the physician’s collected fees.

Taken all together, the case law and statutes form a complex balancing act. The Texas Medical Association recently published a white paper detailing its explanation of the doctrine, and it largely reflects the views of AmSpa on the matter. Additionally, the medical service organization (MSO) model allows medical spas in Texas a way to navigate these situations. If you are not familiar with the MSO model, see articles about it here and here, and the concept will be covered by an attorney from ByrdAdatto at the upcoming AmSpa Medical Spa & Aesthetic Boot Camp in Dallas. Because of the highly technical nature of the CPOM, the board’s FAQ recommends that you consult an attorney before entering any actual arrangement. Also, do not base your business plan on any article, even—and especially—this one. You need specific and tailored advice from an attorney who is intimately familiar with the Texas CPOM, professional organizations law and medical spas.

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

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Can I Reward My Medical Spa Patients for Referring a Friend?

Posted By Administration, Monday, September 9, 2019

gift card exchange

By Robert J. Fisher, JD, ByrdAdatto

We at ByrdAdatto receive numerous questions each week from providers, medical spas, wellness counselors and other businesses in the aesthetic space. These questions range from entity structuring to employee disputes to lease negotiations, but questions relating to patient reward programs for referring friends are among the most frequently asked.

Patient referral rewards come with multiple overlapping layers of laws and regulations. In order to understand the risk you might incur by using these referral programs, it is critical to seek advice from a health care attorney before implementing a rewards system or referral incentive initiative.

The federal Anti-Kickback Statute is the starting point for understanding the implications for rewarding a patient for referring a friend. This law states that providers cannot offer remuneration in cash or in kind to induce the referral of a business or service covered by a federal health care program. Stated another way, a provider cannot give a person gift cards, cash, discounted services or anything else of value in exchange for referrals when federal insurance programs, such as Medicare and Medicaid, are involved. The federal Anti-Kickback Statute likely does not apply to your aesthetic practice, since such aesthetic practices are typically cash-based, but it serves as an important building block.

Most states have their own version of an anti-kickback law that uses the federal language as a base, but broadens the restrictions to varying degrees. For example, Texas, New York, Florida and California all have laws that prohibit providing remuneration to a person for referrals, regardless of whether patients are paying with cash or insurance. In these states, giving a patient cash, gift cards or generally anything of value for referring a friend will create the risk of violating the state anti-kickback law. On the other hand, Illinois law only prohibits remuneration for referrals when insurance is involved and does not regulate paying for referrals where the practice is cash-based.

Finally, the regulatory boards—medical boards, nursing boards, etc.—can issue their own rules and regulations that tighten or otherwise modify state anti-kickback laws. Continuing the Illinois example, while its state law does not prohibit providing remuneration for referrals when cash payors are involved, the medical board has opined that it views this practice as unprofessional and unethical. This can result in a medical provider being at risk for loss of license, reprimands, fines and more from the medical board if he or she pays for referrals.

The complexity of health care laws and the importance of identifying the laws applicable to your practice make the risk of creating a patient referral program without talking to a health care attorney too great. There also may be alternative solutions to boost patient numbers, such as installing membership discount systems, that avoid creating a regulatory headache.

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 become the next med spa success story.

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

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