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Highlights from the SOLD OUT Medical Spa Show 2019

Posted By Administration, Wednesday, February 27, 2019

Did you make it to Las Vegas for The Medical Spa Show 2019? We had a great time and whether you made it or not, we hope to see you at MSS 2020!

See some highlights from the show below, and if you have pictures you want to share, post them on social with the hashtag #MedSpaShow2019!

AmSpa’s CEO, Alex Thiersch, presented to over 900 medical spa professionals about the current state and legal landscape of the medical spa industry.

According to AmSpa's 2018 State of the Industry Report, 82% of industry professionals have been in the industry for less than 10 years! The industry is young and people are flooding into the market.

80% of med spa facilities are a single location, and of the remaining 20%, most have no more than 2-3 locations. This is an industry of mom-and-pop stores where you can open up and make a difference, and it's one of few industries that you can succeed and flourish just on your own!

Allergan sponsored the Members-Only reception, where AmSpa members networked and traded notes about their experience in the industry. AmSpa’s membership network has grown to over 2,000 members, and we were very excited to meet new members and our super fans!

AmSpa’s Glam Celeb Duo, Dr. Sheila Nazarian and Glam RN, greeted guests on the red carpet at The Opening Night Party. 

AmSpa attendees fiercely competed in the app game for a chance to win luxurious prizes including 2 Gucci Bags, a Luis Vuitton bag, an iWatch, an all expenses paid trip MSS20 and an all expenses paid trip to the Next Level! event – courtesy of AmSpa.

The Social Media Glam Stars met their super fans after the Social Media panel, “How to Gain Thousands of Social Media Followers and Why It’s Important”

What Happens in Vegas, Doesn’t Always Stay in Vegas … and some attendees have the AmSpa tats to prove it!

We loved having you, and we'll see you again next year at #MedSpaShow2020, Jan 31-Feb 2, 2020!

Tags:  The Medical Spa Show 2019 

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Suit from Laser Hair Removal Injuries Highlights Need for Training and Oversight

Posted By Administration, Monday, February 25, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

If you are thinking there is a lot of Medical Spa related news coming from Houston, TX, you would be right. We’ve previously commented on some criminal medical spa issues here. And, today, I want to draw your attention to a recent civil suit filed in Harris County District Court by a man who received multiple painful and sensitive burns on his legs and trunk as a result of an improper laser hair removal procedure. According to the article the specific laser machine was new to the medical spa and during the procedure the plaintiff recalls hearing the employee say “uh-oh.” 

“Uh-oh” is something you never want to hear during a haircut let alone a medical procedure. This highlights a topic we have touched on several times: while laser hair removal (LHR) and other procedures can be very safe, they are not without risk of injury or complication. It is critical that individuals who perform these procedures have proper training and skill not only in the device itself but the underlying human physiology at play. Often this medical knowledge will be gain in acquiring a professional health care license or it may be provided under the supervision of a physician or other qualified health care professional. 

Most states recognize the importance of having this medical oversight of these procedures. Whether it is, as most states do, by treating laser hair removal as a medical procedure or, as in states such as Texas or Florida, by having licensed laser technicians who practice under a consulting physician, a medical professional is involved at some stage in the process. (AmSpa members may review their state summary for details on their state’s laser laws.)

The major exception to this is New York where laser hair removal is not regulated by any organization. We’ve previously discussed the efforts to pass legislation and this year’s Assembly Bill 821 that seek to bring the LHR industry under regulation. AB821 would create training requirements for LHR technicians and require that they practice in facilities overseen by a consulting physician. 

However, 2019 could also see Arizona replace New York as being the wild west of LHR laws. A Bill introduced in Arizona’s Senate this year would reduce oversight of their laser technicians allowing them to practice under a “laser safety officer” who does not require any sort of medical background. Even more notable is that laser technicians in AZ are not limited to LHR but may also perform other laser and light based skin procedures. Procedures that carry a much greater risk of complication or adverse outcome all without any medical professional oversight or supervision.

As covered before, in order for the Medical Aesthetic Industry to continue to grow and thrive it needs to have practical rules. Part of insuring this is operating in a way that maximizes patient outcomes, minimizes complications, and avoids drawing negative attention. Having properly trained and supervised people to perform the procedures is a huge part of this. State Legislatures pass legislation reactively and overly restrictive laws get passed in reaction to shocking news. For instance, Virginia enacted their LHR regulations in the wake of a lurid news story where a patient was burned after receiving treatment performed by the clinic’s janitor.

Again, we don’t have any details on the training or supervision involved in the above LHR lawsuit from Houston. In general, a person with better training, education, and skill in the procedure, the device, and with medical supervision is going to have fewer “uh-oh”  moments than a person who only has the minimum training. Eliminating “uh-oh” moments is a critical step to long term success for both your Medical Spa and the Industry at large.  

Tags:  Med Spa Law 

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Rethink Your Math: Discover How Offering Payment Options Can Build Longer, Stronger Client Relationships Than Discounting

Posted By Administration, Wednesday, February 20, 2019

By: Karen Zupko, on behalf of CareCredit

I'd like to dispel a common myth our team hears from clients, which is that they can build a loyal customer base by offering rash and random discounts. 

Such discounts appeal to what researcher Paul Wang, PhD defines as transaction buyers, whose psychology is: "I want to get the best deal." They come for the price, and they’ll leave for the price. 

Think about your price conscious guests, who may ask if you are able to price match another spa. While your goal is to ensure they have an unsurpassed spa experience, at the end of the day, their main focus will always be the cost of the service not the quality of their experience. [1] That’s why it’s best to maintain the value of your services and avoid offering continuous discounts. As an alternative, here are some ways to leverage your spa’s payment options to optimize your client’s experience. 

1. Train your team to identify whether guest hesitation is a budget or cash flow issue.

This answer will help you tailor the message. If the guest truly can't afford the treatment, it's a budget issue. Offer a less expensive service or product. If they can afford it, they may be uncomfortable paying for the whole treatment at once. Resist the urge to discount! Instead, let them know you accept the CareCredit health, wellness and beauty credit card as a payment option. CareCredit's online calculator allows your team to run payment scenarios in seconds.

Example:" I realize that $1,200 is a lot all at once. We offer a 6-month promotional financing option with the CareCredit credit card. Let’s look at what your monthly payment could be." 

2. Combine promotional financing with a special offer that addresses a specific issue. 

For example, to introduce a new aesthetician or drive volume to pay for a new laser, think strategically. Who would like to know you are offering a new treatment or service? Existing guests, of course. 

Create an email or mailing to all guests seen over the last two years. Announce the new staff or service available and offer a special limited time price for a select service. A simple sentence explaining that special financing options are available with the CareCredit credit card completes the message.

3. Generate the unconverted quote report and create a "schedule filler." 

For example, in summer months that are often slow, contact guests who left the spa with a quote for laser hair removal, or fillers, but have not yet scheduled. Send them a personalized note such as the sample below.

"When we last spoke about laser hair removal, you were exploring your options and cost seemed to concern you. If you've not yet scheduled with another spa, and your schedule is flexible, we'd like to offer you a reduced fee if you schedule in June or July. I know you'll be buying back to school clothes and supplies for your two kids at that time, so you might want to use our 6-month special financing options through the CareCredit credit card to pay over time*! 

4. Think "velvet rope."

"Exclusives" work better than giving discounts to everyone. Don't blast out special offers to everyone in the email database or post them to Facebook. Make it feel personal and exclusive.  

For instance, mine your database for guests who are regular skincare product purchasers. Send invitations for a special event that discusses CoolSculpting or laser treatment and encourage them to invite a friend. Explain payment options as part of your presentation and have an iPad on hand for people to easily apply for the CareCredit credit card . All attendees leave with a goodie bag that includes information about the CareCredit credit card and a special treatment pricing offer valid if scheduled within one month.

5. Combine CareCredit's Available Credit report with a targeted offer.

This highly useful report is available in the CareCredit provider portal. It displays people who have been approved for CareCredit, along with the amount of available credit on their account. Develop several, limited time specials at different price points and contact people whose available credit amount is a match.

Whether you contact them by phone or email, nuance and word choice are important. Here are a few helpful conversation starters and things to avoid:

 Don't Say Instead Try
"I noticed that you have $800 to spend using your CareCredit credit card."

"We're contacting you about our THERMI special offer. For those who use CareCredit's 6-month or 12-month special financing option, we are extending a special price of $____ and our records show that you are the perfect candidate for this limited time offer."

Subject to credit approval. Minimum monthly payments required. See for details.

“You have $700 left to spend on your CareCredit credit card, would you like to rebook now?” “We noticed that last time you visited us, you received a laser treatment with one of our technicians. So, we thought you might be interested in learning about some of our similar treatment options. We would love to book a consultation for you with one of our estheticians. Right now we are offering an exclusive price if you were to use your CareCredit credit card for payment. 

Try these 5 tips to in your spa today and see how using CareCredit can help build strong client relations without having to discount services. If you don’t accept CareCredit there is no cost to enroll. Get started today! Visit 

[1] This service cannot be utilized in Day Spas, Med Spas only.
*Subject to credit approval. Minimum monthly payments required. See for details.

These simple tips have been provided by Karen Zupko on behalf of CareCredit. Karen is president of KarenZupko & Associates, Inc., She has been advising aesthetic practices about marketing and management for more than 30 years.

About CareCredit: CareCredit is a health, wellness and personal care credit card dedicated to helping people get the care and treatments they want and need. For more than 30 years, CareCredit has helped millions of people by offering special financing options with convenient monthly payments. CareCredit is accepted at more than 200,000 locations for a wide variety of health and wellness procedures, treatments, products and services. CareCredit is a Synchrony solution. Synchrony is the largest issuer of private label credit cards in the U.S. based on purchase volume and receivables. Visit to learn more.

This content is subject to change without notice and offered for informational use only. You are urged to consult with your individual business, financial, legal, tax and/or other advisors with respect to any information presented. Synchrony and any of its affiliates, including CareCredit, (collectively, “Synchrony”) makes no representations or warranties regarding this content and accept no liability for any loss or harm arising from the use of the information provided. All statements and opinions are the sole opinions of Karen Zupko. Your receipt of this material constitutes your acceptance of these terms and conditions.

Tags:  Sponsored Content 

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How Can A Consultant Help Your Medical Aesthetics Practice?

Posted By Administration, Friday, February 15, 2019

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

The work of a consultant can be extremely valuable for a medical aesthetics practice. When you spend every day operating a medical spa, it can be very difficult to determine why certain things are working and others are not. Ideally, you would be able to step back and view your business with a critical eye, but for numerous reasons, that simply can’t be done

If you’re thinking about why a program you designed isn’t working out, for example, it’s difficult to set aside the amount of work you put into creating it and look at what’s wrong with it objectively. That program is a bit like your child—you put an incredible effort into it, and while you know it isn’t perfect, you won’t hear others speak ill of it. However, sometimes you need someone to tell you that something is wrong, and that’s where a consultant comes in.

A consultant can take a look at your business using unbiased eyes and years of experience in the industry. Consultants aren’t parts of your organization, so they can look at it with an unbiased view. They can see what you’re doing right and what you’re doing wrong in ways that someone who has skin in the game simply can’t, and they can help you determine a suitable course of action for correcting the problems with your organization.

Of course, you may want to bring in a consultant to help you finish a major project or help install a new dimension of your business, and that’s another perfectly viable way to use his or her talents. A good consultant has been part of the industry for many years and has seen what works and what doesn’t, so having him or her help you create a new part of your business can help it get off the ground efficiently and avoid problems that programs created without outside expertise may encounter. 

A consultant can even help a company in ways that might compromise a full-time employee, in that he or she can say what needs to be said without any fear of recriminations. They might even be called upon to make decisions that someone in the organization simply can’t make because of their proximity to the principles involved.

And while a consultant’s time certainly isn’t cheap, it’s a bargain when compared with the damage that inaction can do. What’s more, a consultant isn’t an employee, so you don’t need to worry about paying taxes or conferring benefits, and depending on the contract you negotiate with him or her, you can scale the amount of work in accordance with what you need. 

If your medical spa needs a fresh set of eyes on a problem or a new voice to propose a solution, consider bringing in a consultant. A medical spa might seem like a closed system, but it doesn’t have to be. An outsider can help your business become the best it can be.

As with last week’s blog about mastermind groups, you may be wondering why we’re bringing this up in this space. Stay tuned to find out.

Tags:  Med Spa Ownership 

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Med Spa Slammed with Class Action Lawsuit for Violating TCPA

Posted By Administration, Thursday, February 14, 2019

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

Ever heard of TCPA? 

Most people haven’t. 

It stands for Telephone Consumer Protection Act. And it’s the second most frequent federal lawsuit after employment law claims. And now a med spa is on the receiving end

Simply put, it’s a cash cow for plaintiff’s attorneys. And why not? As Willie Sutton once opined… he robbed banks because that’s where the money was. 

What is it and what triggers it?

In 2019, TCPA is mostly triggered by SMS text message marketing. The business send offers to its prospects by text message. Text messages are generally opened and read. It’s effective.

SMS texting implemented by automated systems is regulated by the Telephone Consumer Protection Act of 1991 (TCPA). TCPA is enforced by the FCC. The FCC updated its TCPA regulations in July of 2015. And there’s a recent appellate court ruling which considered whether the FCC over-reached. That ruling created more questions than answers. The litigation machine roars on. 

Initially, TCPA was designed to prevent dinner being interrupted by pre-recorded junk marketing calls to landlines. That was in 1991. When we had land lines and actually ate dinner together. Today, TCPA mostly tackles text messages. 

The statutory damages for violating TCPA is $500 per text or actual damages, whichever is greater. The statutory damages are up to $1,500 per text for willful or knowing violations. 

It doesn’t take much for this number to get large quickly. 1,000 x $500 = $500,000.

Because the number can get large quickly, class action lawsuits in this domain are enticing to attorneys, even when a business has done everything right. There is no cap on aggregate statutory damages. Multi-million dollar settlements are not uncommon. 

In Kolinek v. Walgreen, Walgreens settled a class action suit for $11 million. What horrible thing did Walgreens do? A consumer provided his mobile number to Walgreens when he picked up a prescription. The pharmacist allegedly stated the number would only be used to verify his identity for future refills. Walgreens then sent messages reminding the consumer to pick up his refills. (Here, the number was not actually used to “verify his identity”; it was just a helpful reminder about refills.) The consumer filed a TCPA class action lawsuit. Multi-million dollar settlement. By the way, each consumer received about $20. The lawyers received millions.

How does a business prevent such mischief? If the text message is advertising or marketing, the business must obtain express prior written consent from each consumer who will receive a text. The consumer cannot be charged for the text. There’s a laundry list of items that must be included in a consumer’s written consent to be TCPA compliant. And the burden is on the business to obtain this consent. Getting this consent is like getting HIPAA consent for every consumer – yet again.

We’re sure a business that sells TCPA services will tell its clients not to worry. But, are they willing to indemnify the client for potential multi-million dollar judgment? Most errors and omissions or general business liability policies do not cover TCPA claims or they explicitly exclude TCPA claims. Medical malpractice insurance claims do not cover TCPA claims. 

At least with medical malpractice, a plaintiff needs to allege an injury. The doctor is typically covered with medical malpractice insurance. And many states cap damages. 

With TCPA, the sky is the limit. The mistake can be innocuous. And insurance is generally not available to ease the sting.

Still, it IS possible to promote robust SMS text message marketing campaigns and comply with TCPA. The time to get this right is before there’s a problem. 

Tags:  Business and Financials  Med Spa Law  Med Spa Ownership 

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What Is a Mastermind Group?

Posted By Administration, Tuesday, February 5, 2019

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

In business, every idea is valuable. Internal brainstorming can only offer you so much, since it may reflect your company’s corporate culture in ways that limit its efficacy. However, from day-to-day, you are likely far too busy managing the operations of your business to seek out and consider ideas from outside your immediate circle. Therefore, it is important for business leaders to seek out ways to interact with peers from around the world in order to help develop new ideas and keep their companies on the cutting edge of their markets.

Participation in mastermind groups is a very successful way business leaders develop new and exciting ideas. Initially named by noted self-help author Napoleon Hill in 1925, this concept involves a group of entrepreneurs who get together to give each other support, talk about their business, knock each other down and build each other up, and make themselves available as resources. This idea isn’t exactly new—for example, Benjamin Franklin founded a group called the Junto in 1727 that was designed to provide mutual improvement for its members. Franklin was inspired by numerous other similar groups throughout history. Nowadays, these groups convene once a month, usually as a teleconference, and during the meetings, each person will be given a limited amount of time on the “hot seat,” when his or her ideas are reviewed and evaluated.

However, the structures of such meetings and even of the groups themselves are flexible and can be amended to better reflect the circumstances in which they exist. In the aesthetics industry, for example, many resources are available to practice owners and operators, but much of the information out there is very topical and may have limited utility for many members of the group. Therefore, a mastermind group based in the medical aesthetics industry might hypothetically benefit from a certain amount of curation—the groups should be kept small and grouped according to factors such as revenue, location, business cycle, personality, etc. Because the groups are small, the members can go into greater depth during their “hot seat” segments and learn more about issues endemic to their particular section of the industry. What’s more, these groups should also consider having a business coach in order to help group members get into an entrepreneurial mindset to better build their companies.

People who have participated in mastermind groups typically give the process positive evaluations. When knowledge is coordinated in such a way, it provides tangible benefits to those who participate, and helps create accountability that often carries over to members’ standard business. These groups can also help members look at problems and develop solutions in ways they wouldn’t have otherwise, and encourage participants to reach for levels of success that they may previously have thought unobtainable.

If you find the idea of mastermind groups intriguing or potentially beneficial for your business, be sure to keep an eye on the news that comes out following The Medical Spa Show 2019, which takes place at the Aria Resort & Casino in Las Vegas, February 8 – 10. 

Tags:  Med Spa Ownership  Med Spa Trends 

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The Medical Spa Show: It's a Celebration!

Posted By Administration, Wednesday, January 30, 2019

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

If you’re a reader of this blog, you likely are well aware of the fact that the Medical Spa Show 2019 will be held in Las Vegas on Feb. 8 to 10 at the Aria Resort & Casino. Putting this show together has taken a lot of hard work from everyone here at AmSpa, but it’s worth it to us, and we’d like to take a moment to try to explain why.

More than anything, we view this show as a celebration of the medical aesthetics industry. Medical spas have always been just outside the norm, from both medical and marketing standpoints. With regards to the medical space, there is no board certification for aesthetics, so it has always been a specialty that is somewhat difficult to define. And of course, because the medical aesthetics industry is entirely cash-based, marketing is much more important than in any other sector of the medical space, and maintaining compliance is trickier, as well.

With more than 1,000 medical aesthetics professionals coming together in one place at one time, the Medical Spa Show 2019 is a unique opportunity to not only discuss how to improve the industry in terms of compliance and business-building, but also recognize some of the exceptional people who are out there doing incredible things. 

Over the past year, I’ve spoken with countless entrepreneurs who are opening and running medical spas, and I’ve come away impressed by how supportive the industry is, as well as how innovative it has become. Many of the major advancements in the medical field in recent years have grown from work that was done in the medical aesthetics industry, and I think that tends to get overlooked.

We’re also beginning to see specialization enter the industry to an unprecedented degree. These are cool concepts—small injectables-only practices, practices that are designed to cater to specific demographics, and so forth. I also believe that the emergence of subscription-based membership programs is capable of taking the industry to a whole new level of success, and this is the kind of innovation that can only take place in a place where business and medicine intersect. Dermatologists and plastic surgeons aren’t the ones who are cracking this—medical spas are.

We will also celebrate the industry’s success. This year, for example, Crystal Clear Digital Marketing was recognized as one of the fast-growing companies in the country by Inc. magazine, and they primarily operate in the medical aesthetics industry. It is a dynamic company that is growing very quickly and making a national name for itself, and it is not the only one that will be represented at the Medical Spa Show. Practices are growing into chains, the industry is opening up, and we’re going to find out how to make it even bigger.

A lot of the things that were thought by core doctors to be outside the realm of possibility 10 years ago are happening right before our eyes, and it is because of the pioneering mindset that emerges when business and medicine intersect. You can meet all the people driving this innovation at the Medical Spa Show 2019, because they’re all going to be there under one roof, sharing their ideas and the secrets of their success. If you’re coming, we’re looking forward to seeing you there! If not, consider joining us at next year’s show—it’s a great opportunity to learn about the industry and maximize your business.

Tags:  The Medical Spa Show 2019 

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Should Your Med Spa Offer Aesthetician Services?

Posted By Administration, Tuesday, January 29, 2019

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

While medical spa services command higher prices than traditional spa treatments, medical spa owners and operators shouldn’t overlook aesthetician services. These can be lucrative opportunities for added services for your patients, increasing both retention and profitability of your med spa practice.

What Can Aestheticians Do For You?

According to the American Med Spa Association’s 2017 Medical Spa State of the Industry Report, aesthetician services were one of the leading revenue-generators in medical spas. These treatments can include facials, aesthetician-grade chemical peels, and waxing, to name a few. This category also includes Hydrafacials, which is one of the fastest-growing treatments in medical spas regardless of practitioner type.

Some Caveats

In many states, treatments such as microneedling and dermaplaning are considered to be the practice of medicine. Because of this, they should only be done by a licensed medical professional. However, there are some situations in which a person holding an aesthetician license may perform these procedures.

Microblading is also a treatment that individuals holding aesthetician licenses perform in many states. State laws can vary regarding this procedure, but it is often categorized as permanent makeup and, with some additional training, these practitioners can often offer this service in medical spas.

Contact an attorney familiar with medical aesthetic laws in your state for more information on microneedling, dermaplaning, or microblading. (AmSpa members can take advantage of their annual complimentary compliance consult with the law firm of ByrdAdatto, or check their medical aesthetic state legal summary.)

Legal Requirements
To add these aesthetician services to your medical spa, first be sure that the practitioners you hire are properly licensed to perform these treatments. This should be of paramount importance for all of your service providers, whether offering beauty services or medical treatments. In-depth training and proper licensure ensures that your patients are getting the best possible services and results, and also protects your staff and business against fines and other punishments from regulatory agencies. Your business will also need to obtain an establishment license for these procedures, and that license must be displayed in your facility during business hours. Additionally, be sure to double check with your insurance-provider to make sure you are covered to offer these additional treatments. Assuming that your other business housekeeping is in order (LLC, tax ID, etc.), you should now be set to offer another tier of services to your clients.

For more information on medical spa legal best-practices attend The Medical Spa Show 2019 or one of AmSpa’s Medical Spa & Aesthetic Boot Camps.

Tags:  Med Spa Law  Med Spa Trends  The Medical Spa Show 2019 

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New York’s Laser Hair Removal Problem

Posted By Administration, Tuesday, January 22, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

Laser hair removal (LHR) is one of the most commonly performed non-invasive aesthetic procedures in the U.S., and almost everywhere, it is regulated the same. Most states view LHR as a medical procedure that requires proper training and physician supervision. In a few states—including Georgia, Texas and Massachusetts—non-physicians may perform LHR without physician supervision, provided it is within their scope of practice and they meet certain requirements. In Georgia, for example, a non-physician can apply for and obtain a Cosmetic Laser Practitioner’s license, provided they complete certain courses—and pay a $200 fee, of course.

But in New York state, LHR is entirely unregulated, and thanks to a article titled “Marked” by Elizabeth Roy Stanton that was published by Medium in December 2018, this fact is receiving national attention. “Marked” is a harrowing account of how Stanton’s decision to undergo LHR at a salon in Scarsdale, N.Y., resulted in physical scarring. (AmSpa and ByrdAdatto aided Stanton in preparing the article.)

“At some point in the past, the medical board declared that lasers, when used for hair removal only, are not the practice of medicine, so they don’t oversee who does it,” said Patrick O’Brien, legal coordinator for AmSpa. “There’s no other regulatory body, so laser hair removal is unregulated in New York. Essentially, anybody can go buy a laser, open up a shop, and start doing laser hair removal.”

This relates only to laser hair removal—other uses of lasers in aesthetics are considered to be medical in nature and therefore are regulated by the state medical board and require physician supervision. In the years since the board declared that it did not consider laser hair removal to be medical, the state has attempted to close this loophole, but its efforts have as yet been unsuccessful.

“[The state legislature] tried for several years to pass some kind of licensing regulation,” O’Brien said. “They had a bill last year, but I believe it didn’t gain any traction from medical groups because the bill would have allowed non-medical persons to perform [LHR]. I believe the one before allowed you to become licensed, just like you’d become licensed for doing tattoos or becoming an esthetician.”

On January 18, 2019, a new bill that would create a LHR licensure procedure was filed in New York. This would create a situation similar to Texas’ LHR law, which allows licensed individuals to operate largely independently, though they are required to submit to periodic oversight by a physician. However, it remains to be seen if it will be passed into law.

“It seems like the trend is to create a separate license,” O’Brien said. “Most states treat it as a medical procedure, and so a doctor has to supervise it, but many are seeing that it is relatively safe and that people, with training and being properly overseen, can do it. I think you’ll see states move to open it up to more people, just because it’s so common.”

Stay tuned to AmSpa for more details as this story develops. And if you’d like to learn about the laser laws in your state, join AmSpa or consult an experienced health care attorney.

Tags:  Med Spa Law 

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Off-label Considerations for Mid-level Practitioners

Posted By Administration, Friday, January 18, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

We’ve discussed the issues and legalities with prescribing drugs for uses other than what the FDA originally approved them for here. Known as “off-label use” the practice is often routine and generally acceptable as the FDA does not control the practice of medicine.  Most of the current discussion looks at off-label use from the perspective of licensed physicians.  Generally, physicians are permitted to prescribe drugs for off-label purposes without restriction as part of their license to practice medicine.  However, this isn’t necessarily the case for mid-level prescribers such as physician assistants (PA) and nurse practitioners (NP). Below we’ll discuss some of the common limitations and concerns mid-levels face in prescribing off-label.

One of the least common types of off-label restrictions are placed on particular drugs or for particular purposes.  A few states have adopted specific prohibitions against off-label uses for certain classes of drug or for treatment of specific conditions.  These tend to be passed in relation to controversial topics or as a result of a publicized scandal. As an example, Mississippi prohibits all off-label uses for drugs prescribed for the sole treatment of weight loss.  And in North Carolina prescribers working through telemedicine are prohibited from prescribing medications for the purpose of inducing an abortion and this extends to any drug with a known off-label use as well.  

Far more common are discretionary restrictions that a supervising physician may place on a mid-level practitioner. In most states, PAs and NPs derive their prescriptive authority from a collaborating or supervising physician.  This is normally embodied in a mutually written agreement between the physician and mid-level, sometimes requiring board approval.  These are known by various terms such as “practice guidelines” or “supervision agreements”.  These agreements typically outline the procedures and scope of practices that the mid-level is able to perform.  Where these agreements define the scope of the mid-levels prescription authority it will include the types or classes of drugs prescribe and the situations and conditions when they can prescribe them.  So the ability of PAs and NPs to prescribe off-label in these states is largely dependent on if they are authorized by their physician.  This is the case in North Carolina where a PA’s prescriptive authority is governed by their written supervisory agreement with a physician.  They have no blanket restrictions on off-label uses but a supervising physician could restrict their PA to only prescribing for on-label uses in the practice agreement.   

Most states do not have explicit prohibitions on off-label prescribing by mid-level licensees.  Instead, they may have more general rules on mid-level prescribing that may indirectly impact their ability to prescribe off-label.  These more general rules usually take the form of a Formulary or a restriction as to the standard of care. A formulary is a list of included or excluded drugs that are within the mid-levels prescriptive authority. They are usually collectively developed and maintained by the medical, nursing or pharmacy boards.  Unless each board maintains their own.  For instance, Oklahoma maintains separate formularies for both PAs and NPs.  Each formulary includes a list of drugs the licensees are prohibited from prescribing on their own and the PA also lists classes of drugs that are permitted.  It is in these formularies where some off-label uses for certain drugs may be prohibited directly or indirectly by excluding entirely a class of drugs and not accounting for alternative uses. 

Restrictions on prescribing under “standards of care” are typically found in the statute that grants the prescribing rights to the PA or NP.  The prescription is usually worded to allow prescribing for approved uses unless certain requirements can be met.  Usually, the requirements are that the off-label use is supported by studies or peer-reviewed and is included in the current standard of care for that ailment.  For instance in Pennsylvania  the formulary for PAs allows them to prescribe for a purpose other than what the FDA has listed as indications only if two requirements are met:  1)the supervising physician must authorize the particular off-label use and 2) the use must be supported by peer-reviewed literature from a “recognized body of knowledge”. So PAs in Pennsylvania would be able to prescribe off-label generally if their supervising physician approves it and if the use is already tested and supported by research.  A similar “standard of practice” prescribing restriction can be found in for NPs in Texas.  The Texas Board of Nursing’s administrative code limits NPs to ordering and prescribing medication only for FDA approved uses unless the use is part of an official trial or review board or if the use is both supported by evidence-based research and within the current standard of care for treatment of that particular condition.  While those carve-outs will allow Texas APRNs to prescribe medications for many off-label situations it limits them to only those mainstream off-label uses.  NPs in Alabama have similar requirements to only prescribe off-label if it is part of the current standard of care, supported by evidence-based research, and approved by the collaborating physician. Oregon has a more lax form of this “standard of care” restriction. NPs in Oregon have fully independent prescriptive practice; they don’t have to collaborate separately with a physician.  Oregon NPs are specifically permitted to prescribe for off-label uses but only so long as there are appropriate indications and documentation for those uses.

Restrictions like these can have substantial restrictions on PAs and NPs practicing in medical spas and other similar settings.  Many of the more innovative procedures offered in medical spas do not necessarily have an FDA approved indication and may be too new or too niche to be backed up by the required peer-reviewed studies or research.  Mid-level practitioners who practice in medical spas need to be sure that their state doesn’t have any explicit restrictions on the drugs or the uses that they plan to practice within the medical spa.  But in addition to that, they will want to ensure that they have sufficient documentation and research on file to support these off-label uses as being part of the “standard of care”. 

If you are a physician assistant or nurse practitioner in the aesthetic medical field and are interested in learning about new procedures and legal issues surrounding medical spas you should consider attending the Medical Spa Show taking place in Las Vegas, NV, February, 8-10, 2019.

Tags:  Med Spa Law 

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