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Hyaluronic Injection Pens: What You Need to Know

Posted By Administration, Wednesday, January 15, 2020

hyaluronic acid

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

 In the past several months, you may have noticed an explosion of ads, social media posts, articles, videos and training events talking about an “incredible” new injection device that can place hyaluronic acid filler in the skin without using a needle. These devices are often marketed as “non-invasive” or “non-medical,” using names such as “hyaluron pen” or “hyaluronic acid atomizer.”

However, make no mistake—just because they do not have needles does not mean these products are not medical devices or that they can be used without risk. On September 13, 2019, the Canadian Department of Health issued a warning regarding these devices. It stated these injectors pose health risks and are not authorized for sale in Canada. In the U.S., while no state has publicly commented on these devices yet, “administering medication,” no matter the method used, is part of the definition of each state’s “practice of medicine.” Therefore, these needle-free injection devices should be treated the same as traditional syringes. People wanting to perform these treatments still need to have the same type of professional license they would need to inject using a needle and syringe, and they will still need to work under the supervision of a physician or another appropriate professional.

No Needle, No Problem?

Needle-free injection devices generally are used to deliver vaccines and medications either intramuscularly or subcutaneously, similar to a traditional needle and syringe. They work by creating a very narrow high-pressure jet of medication that is able to penetrate the skin; the jet is generated using gas or spring pressure to force the medicine through a small opening in a disposable vial. The benefits claimed include lower chances of cross-contamination, reduced needle-stick injuries, and less sharp medical waste. This makes these devices particularly well suited for inoculation campaigns, clinics and home self-administration of insulin or other medication.

Medical devices and substances may not be marketed in the United States without obtaining U.S. Food and Drug Administration (FDA) approval. FDA approved or classified devices may be marketed only for their approved use. For FDA registration, needle-free or jet devices fall into three broad groups:

  1. General-purpose injection devices meant to be used for injecting drugs that work in needle-free systems;
  2. Devices meant for a certain class of drugs, such as insulin, or use with a specific manufacturer’s specific product line—both of these groups are considered class II medical devices; and
  3. Devices intended to be marketed with a specific product, either labeled for use or sold together, and therefore treated as a combination device.

The first and second group of injectors are regulated using the premarket notification process under the 510(k) provision. These premarket notifications are granted when a new device is substantially similar to an existing approved device, and they allow the manufacturer to begin marketing the product while it complies with the more lengthy registration and approval process. In order to be cleared in this process, at least one drug or injectable substance must already be approved for this method of injection.

A number of needle-free and jet injectors have these filed premarket notifications with FDA; however, none of the “hyaluronic pens” currently on the market appear to correspond with any of these premarket notifications or be from manufacturers who have applied for one. Additionally, FDA has approved a number of hyaluronic acid-based fillers for injection using the traditional needle and syringe method. Thus far, no hyaluronic acid fillers have been approved for use in needle-free injectors. So, any pen injector under the premarket category would need to be compatible with an approved substance other than hyaluronic acid, and, once approved, could not be marketed for use with hyaluronic acid-based fillers.

The majority of the hyaluronic pens currently listed online are packaged with a supply of hyaluronic acid, which would most likely place them in the third category. Devices in this category are considered combination products and can be marketed for that specific use and product after approval. It does not appear that any of the currently marketed “hyaluronic pens” have any FDA approval for their use as Class II devices meant for general injections, and certainly not specifically for using hyaluronic acid.

On the Up-and-up

While no needle-free devices have been approved for hyaluronic acid, several needle-free injection devices have received FDA approval for use with specific drugs, which is something a properly marketed hyaluronic filler device would need to receive. For example, in 2014, a needle-free injector manufactured by PharmaJet and Seqirus Pty. Ltd.—manufacturer of the influenza vaccine Afluria—received approval to administer the Afluria vaccine using the PharmaJet Stratis injector for patients from 18 to 64 years old. FDA made clear, however, that it still recommends sterile needles and syringes for other vaccines and for patients younger than 18 and older than 64.

FDA approvals for both injectable drugs and injection devices are narrow and specific. In the above example, a pediatric office would be in violation if it advertised this service to its patients, since using it on those under 18 is not approved.

Many of these devices are marketed for at-home personal use and can be purchased through several online retailers. Some issues with the marketing of these devices are discussed above, but there are other issues for those who want to use these devices at home.

Safe and Sound

Surprisingly, there are relatively few legal issues for those wanting to treat themselves. While hyaluronic pens can’t legally be sold, they can be possessed for personal or non-medical use. Furthermore, people are generally free to do things for themselves that would normally require a professional license if performed by another—you can cut your own hair without a barber’s license, you can write your own contracts without a law license, and you can treat your fever without being a doctor. Similarly, someone can possess a jet injector for their personal use, as well as possess syringes and scalpels if they so choose. It is worth noting, however, that in some states, possessing prescription drugs and substances—such as injectable hyaluronic acid—without a prescription is prohibited. And offering to perform these treatments on others is considered the practice of medicine without a license.

From a practical standpoint, people should think carefully before choosing to perform medical procedures on themselves. The jet injectors being sold are not designed for this use—they appear to be rebranded and repurposed injectors that are not approved in the U.S. The hyaluronic acid fillers sold with them and available online also are not approved for injection into humans and often are of unknown sterility, safety or quality.

Additionally, much like the concept of “cutting hair,” the concept of using the pen injector sounds very simple. However, just as successfully giving yourself a haircut is far more complex than it seems, performing injections on yourself more complicated than it might appear. Those wanting to perform these treatments should first discuss the risks and potential complications—such as infection, contamination or vascular occlusion—with their physician.

Professional Considerations

Medical aesthetics professionals may be interested in bringing needle-free devices into their medical spa practice. This creates its own set of questions—namely, can you? And should you? Licensed health care professionals can be subject to professional penalties and discipline on their license if they are found to be using non-FDA-approved medication or devices. However, physicians generally are able to use otherwise-approved devices and drugs in ways that are not yet approved by the FDA. This is commonly known as “off-label use,” and it is the source of a great deal of innovation and advancement in the medical field. However, physicians are not allowed to advertise and promote off-label uses. Additionally, using unapproved devices in an unapproved way can create standard-of-care and liability issues for the practitioner if the patient experiences an adverse outcome.

So, while it would not be advisable for a nurse or physician to purchase one of these unapproved, illegally marketed devices off eBay, for example, a physician could take an FDA-approved needle-free injector and repurpose it for injecting FDA-approved fillers, so long as they did not market or advertise this practice. The question then becomes—does it make sense to do this? Do such devices bring additional capabilities over the current syringe-and-needle techniques?

While many of the approved devices allow for the dosage per “firing” to be metered, it does not appear that the placement of the medication can be done as precisely as using a syringe and needle—there is no way to ensure that the filler is injected in the precise location or depth, or in the amount desired. According to studies conducted by jet injector manufacturers, the amount of the drug that is actually delivered and the precise location of delivery can vary from injection to injection. The depth and penetration also can be influenced by tissue density, the angle of the injector to the skin, and the pressure applied against the skin prior to firing.

While these variables can be within acceptable limits for administering vaccines and medicine, would they be acceptable for cosmetic treatments on someone’s lips or face? Additionally, in the FDA’s Afluria/PharmaJet announcement on August 15, 2014, both the study performed for the approval and two prior needle-free injector studies (Jackson et. al. Vaccine 2001, Simon et. al. Vaccine 2011) found that needle-free injections had a higher rate of pain, redness and swelling at the injection site than those who received traditional hypodermic injections. Newer devices may remedy some of these issues, but any licensed practitioner should carefully consider the pros and cons before integrating this off-label use into their practice.

Taking Your Chances

The current crop of “hyaluronic pen” devices that are unscrupulously and illegally being marketed to the public create many issues, even beyond their lack of FDA approval. The public should be extremely wary about using these devices, and under no circumstances should anyone perform this treatment—or any other cosmetic injectable—unless they hold an appropriate health care professional license or are working under the supervision of a physician. Licensed health care professionals should educate their patients about the risks of these at-home, unapproved products and should always carefully consider the benefits of adding a new or novel treatment to their practice.

Tags:  Med Spa Law  Med Spa Trends 

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LAST CHANCE! Book a Room at the Vdara Hotel & Spa as Part of the MSS Room Block TODAY!

Posted By Administration, Monday, January 13, 2020


The Medical Spa Show—which takes place January 31 – February 2, 2020, at the Aria Resort & Casino in Las Vegas—is the premier conference and trade show for noninvasive medical aesthetics, and if you’re planning to attend, you’ll need somewhere to stay. Unfortunately, finding a hotel room in Las Vegas for that weekend is becoming more difficult by the day. In fact, The Medical Spa Show’s original room block at the Aria sold out before it closed.

However, AmSpa has been able to secure an additional room block at the nearby Vdara Hotel & Spa. This block closes at 5pm Central today and definitely will be the final room block offered for The Medical Spa Show. If you want to attend but haven’t yet solidified your plans, you need to register and book your room today to take advantage of this offer.

The Vdara Hotel & Spa is located just across Harmon Avenue from the Aria, and is connected to the Aria via the ARIA Express Tram, which runs from 8am to 4am daily; the ARIA Express Tram is on an elevated electronic track that connects the Aria, the Bellagio, the Vdara, the Park MGM and The Shops at Crystals.

Hotel rooms in Las Vegas are selling out over Medical Spa Show weekend—which also happens to be Super Bowl weekend—and this offer allows show attendees to secure a luxurious room at a great price.

Again, this is your last chance to book a room through a Medical Spa Show room block. After the room block closes at 5pm Central, there will be no further accommodations offered in conjunction with the show.

After you register for the show, you’ll receive the link to book in this limited block in your confirmation email; if you have already registered and still need a room, log into your account and book your room from there.

Tags:  The Medical Spa Show 2020 

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How to Conduct a Practice Assessment for Your Medical Spa

Posted By Administration, Friday, January 10, 2020


By Jay Reyero, JD, Partner, ByrdAdatto

We are all familiar with New Year’s resolutions. At the end of each year, we conduct a self-assessment and set goals for ourselves heading into the new year. Slowly—or in some cases, on the first day—we drift away from those goals only to repeat the cycle at the end of the year and the beginning of the next. Similarly, businesses can find themselves drifting away from goals or compliance standards over the course of the year. In preparing for a new year, medical providers should conduct a self-assessment in the form of a practice assessment.

Gathering all the documentation and information you wish to analyze is the starting point of any practice assessment. In setting the scope of the assessment, you should start with documentation from the following four areas:

  1. Corporate documents;
  2. Financials;
  3. Staffing; and 
  4. Policies and Procedures.

Once these are gathered, you can begin the assessment by identifying whether anything is missing or conflicts with how things are or are believed to be with your business. The hope, though, is that you confirm everything remains aligned.

It also is important to remember that a practice assessment should include analysis by each member of your advisory team. In addition to legal counsel, you should include your CPA, tax advisor and financial advisor for their respective perspectives. Once again, all aspects of your business should be aligned to prevent any issues.

Finally, like New Year’s resolutions, a practice assessment should be an annual tradition. Compliance is not static, and health care is constantly changing, so you need to ensure your business doesn’t fall out of compliance. Unlike the New Year’s resolutions, hopefully your compliance can last longer than a day.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

Jay Reyero, JD, is a partner at the business, health care, 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. His 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:  Business and Financials  ByrdAdatto  Med Spa Law 

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4 Critical Elements for Converting Web Leads into Consultations

Posted By Administration, Wednesday, January 8, 2020


By Terri Ross, Terri Ross Consulting

I’d like you to think about a few important questions:

  • What percentage of your leads are coming from your website?
  • Do you track these leads?
  • How quickly do you respond to inquiries?
  • Do you have a clear, concise process for follow-up?
  • Do you have a dedicated person on staff to handle this?

If you answered “I don’t know” or “no” to any of these, don’t worry—I’m here to help you create a game plan to more effectively convert your web leads into new business.

Did you know that the average aesthetics practice generates 52% of its leads from its website? That is larger than patient referrals, social media, other physicians, referral sites and traditional marketing combined. If you don’t have a carefully thought-out plan, process and practice in place to track and convert these leads, you are leaving money on the table.

Website leads are generally “cold” leads, which means the prospect typically:

  • Is highly cost-conscious;
  • Was not referred by anyone;
  • Found you with an online search; and/or
  • Has some anxiety about results, downtime, pain, recovery, anesthesia, etc.

It is challenging to convert cold leads, as you must be able to quickly respond and clearly communicate your practice’s unique value proposition (UVP).

1. Timing

Web leads are seven times more likely to convert to sales if you respond to them within an hour of contact. If they are looking at your practice online, no doubt they are contacting others as well.

If there is someone within your practice who is able to monitor web leads in real time when they come in (whether it is your front desk administrator, patient care coordinator or office manager), that is the optimal way to ensure you have high conversion rates.

All leads should be entered into your patient management software, and the prospect should be contacted within an hour via:

  1. A call;
  2. An email; and then
  3. A text message.

(Note: Do not leave a detailed message on an answering machine regarding what the prospect called about, as that can be sensitive information.)

If you are unable to reach the prospect, follow up again in 48 hours with a phone call, then an email and then a text. Finally, seven days later, make a final attempt to follow up with a call, then an email and then a text. After that point, you can simply keep their information for your mailing list for upcoming newsletters or promotions.

2. Information Gathering

I cannot stress the importance of information gathering highly enough. Taking the time to input the following information into your software can be the difference between an average follow-up call and one that converts a lead into a paid consultation:

  • Date of initial inquiry;
  • Referral source;
  • Patient demographics;
  • Areas of interest or concerns;
  • Interest level if indicated (immediate, moderate or just gathering information);
  • Date of first patient contact; and
  • Follow-up data.

3. Automated Email

If it is not possible to have a designated staff member monitoring your incoming web inquiries in real time, someone on your staff should be checking on these leads several times a day.

It’s very important to have an automated response email that generates when someone submits a web inquiry. This email should be both friendly and informative, welcoming them to your practice and assuring them that someone will follow up with them within 24 hours.

4. Follow-up Email Etiquette

If a prospect is unable to be reached by phone, the next step is to send a personalized follow-up email. Here are my best practices for follow-up email etiquette:

  • Personalize each email by using address headers with a specific name field rather than keeping it general. This adds a personal touch.
  • Use business etiquette. Be professional and not too casual in both the greeting and the closing. Ensure proper grammar and spelling.
  • Ensure privacy by using a general subject line like “An important message from Dr. XYZ.” Use a “hook” that gives them a reason to open the email.
  • Introduce yourself. Tell the prospect who you are, what you do and what your UVP is. Give your credentials, the details of your staff and what makes your practice stand out from others.
  • Answer the specific question that addresses the prospective patient’s inquiry or provide additional resources. Link to a specific page on your website, procedure information, a brochure or a video about your practice.
  • Remember to include a privacy notice at the bottom of the email.
  • Have a strong call to action asking your patient to schedule a consultation or appointment, along with your hours, phone number and fees.

Remember, I’m here to help you make your practice thrive. If you would like to schedule a call to see how I can train your team to generate more revenue for your practice, please click here.

Terri Ross brings more than 20 years of sales and management experience to the field, having worked with leading-edge medical device companies such as Zeltiq, Medicis, EMD Serono, Merck Schering Plough and Indigo Medical, a surgical division of Johnson.

Ross’ vast knowledge and experience as a sales director managing upwards of $20M in revenue and successful teams has allowed her to become a renowned plastic surgery management consultant helping aesthetic practices thrive.

To optimize revenues and business performance, Ross’ practice management consulting services help physicians evaluate practice processes including, but not limited to, overall-operating efficiencies, staff skill assessment, customer service and operating efficiency strategies. The goal is to develop a comprehensive plan of action to improve productivity, quality, efficiency and return on investment.

Tags:  Business and Financials  Terri Ross Consulting 

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Is It Legal to Practice as a Medical Aesthetician?

Posted By Administration, Monday, January 6, 2020


By Sam Pondrom, JD, Associate, ByrdAdatto

Fake or Real: I am licensed as a medical aesthetician.

Fake! Aestheticians must practice within the state-promulgated scope of practice and only use titles authorized by their license.

To determine their scope of practice, an aesthetician should look to three places:

  1. The state laws defining aestheticians’ scopes of practice;
  2. Any rulings or opinions issued by the aesthetician’s licensing board addressing scope of practice or ability to accept delegation from medical practitioners; and
  3. As it pertains to medical services, the supervision and delegation rules applicable to physicians.

The confusion about the existence of medical aestheticians arises from situations where state-licensed aestheticians have obtained additional education, training, certification and experience, or “competence.” These aestheticians who have sought out and acquired additional competence often believe that they have expanded their scope of practice, meaning they may:

  • Perform tasks or accept delegated tasks normally outside of their scope of practice; and/or
  • Perform delegated tasks with less supervision than a standard aesthetician.

However, this is not necessarily true.

The most important thing to understand about aestheticians is that they are creatures of state law. They must obtain a license from the state(s) in which they practice, typically from the state board of cosmetology. These state cosmetology boards have promulgated regulations and rules that determine licensure requirements, scopes of practice and approved titles. The aesthetician license issued by a state board only allows aestheticians to perform work within the prescribed scope of practice and use the approved title. By designating oneself a medical aesthetician, an aesthetician can be viewed as unilaterally expanding their scope of practice or adopting a new title—or both. These actions may subject an aesthetician to disciplinary action from the cosmetology board.

Complicating this further is that state cosmetology boards have no jurisdiction over the practice of medicine. By adding the term “medical,” aestheticians create another issue for themselves with state medical boards. Generally, when state law defines the practice of medicine with the goal of reserving that practice to appropriately licensed persons such as physicians, they include language protecting the use of titles and descriptors that would lead the general public to believe a person is licensed to practice medicine. Thus, if an aesthetician describes themselves as a medical aesthetician or expands their scope of practice to include services considered the practice of medicine—or both—they may be violating their state’s prohibition on practicing medicine without a license.

Often, we find aestheticians have spent their own time and money on courses that purport to train them to be medical aestheticians, but it is important to consider the source of the training. A quick Google search for “medical aesthetician course” returns many results. But if you look at the course information provided by a company offering medical esthetician classes, you almost always will find some variation of a disclaimer that says aestheticians must look to the law of the state that licensed them for the rules and regulations on their practice.  This means that regardless of what the coursework purports to teach (e.g. lasers, injectables, dermabrasion, etc.), you can only perform the functions allowed by your state’s laws.

We do want to clarify that the point of this post is not to discourage aestheticians—or any licensees—from obtaining education, training and certification to expand their knowledge base. Rather, aestheticians must take the time to fully understand their scope of practice and ability to accept delegated medical services before investing time and money on medical aesthetician classes. Moreover, aestheticians must understand that by advertising themselves as medical aestheticians, they can expose themselves to some level of additional risk.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

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

Tags:  ByrdAdatto  Med Spa Law 

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Marketing vs. Laws: Tips That Might Land You in Hot Water

Posted By Administration, Friday, January 3, 2020


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

In the medical aesthetic industry, marketing is a bit more difficult than in other retail segments. It might seem to make sense for a medical aesthetic facility, medical spa or laser clinic to invest in a flashy ad campaign, complete with lavish praise from patients and offers of discounts; however, going down this path may attract the attention of not only prospective clients, but also state regulators. Here are some ways medical aesthetic practices get in trouble with their marketing efforts, as well as some ways to conduct compliant advertising campaigns.

Understanding the Rules

Even though medical aesthetic businesses tend to engage in the same marketing techniques as other retail businesses—including websites, social media and print advertising—it is important that their owners and operators remember that these practices are, above all, medical practices. And because they are medical in nature, they are subject to the same rules and regulations that govern other, more traditional medical institutions, such as doctor’s offices and hospitals.

Because of this, the ways that a medical aesthetic practice can advertise are very restrictive. The specifics of these restrictions vary from state to state, but they all tend to revolve around the notion that medical care is something that people need rather than choose to indulge in, so any advertising for medical facilities should deal only in facts.

This idea was obviously conceived with traditional medical outlets in mind. For them, the practice of medicine should not be about making money—it should be treating patients in need in their best interest. With this idea in mind, an advertisement for a physician’s services is expected to convey that the physician is an MD, highlight his or her specializations and board certifications, and reveal his or her pricing in an honest and straightforward manner. Furthermore, physicians cannot make grandiose claims of life-changing results or claims of professional superiority—they must only deal in facts.

Of course, medical aesthetic practices are not traditional medical practices, and these somewhat high-minded ideals would seem to run counter to their goals. Medical aesthetic practices deal exclusively in elective procedures and, therefore, may be tempted to make certain claims in order to convince people to choose them over their competitors. However, because medical aesthetic practices are medical practices (it is right there in the name), they must still abide by the rules that govern medical advertising—they must be totally honest.

  • They must specify who is performing medical treatments and what their qualifications are;
  • They must present their pricing in a straightforward manner; and
  • They must not attempt to compare themselves to competitors.

Therefore, if a medical aesthetic practice’s advertising includes words such as “best,” “greatest” or “amazing,” that facility is likely in violation of its state’s medical advertising statutes. A medical spa may operate like a retail outlet, but it cannot advertise itself like one.

Another thing to keep in mind is that if a practice is owned or co-owned by someone who is not a physician—a nurse, nurse practitioner, or entrepreneur, for example—it must make clear in its advertising that it is a physician who is advertising for medical services. For example, if a salon owner contracts with a physician to administer Botox treatments at his or her facility, the salon cannot advertise that it is offering Botox injections—it must specify that the physician is providing that service.

Websites are typically where issues regarding these types of distinctions are found. Many medical aesthetic practice websites state that their treatments are provided by “licensed laser technicians” or “medical aestheticians.” Unfortunately, in most states there are no actual laser certifications, and under no circumstances is any aesthetician permitted to perform medical procedures. The presence of titles such as these on a practice’s website implies that the facility is not structured properly, and it calls into question the credibility of the physician or physicians who are supposed to be overseeing the medical aspects of the practice.

Employees of state regulatory agencies—which are almost always underfunded and understaffed—often simply browse the websites of medical aesthetic practices to determine which of these businesses should be investigated. Using terms such as the ones mentioned above on your website is a good way to attract unwanted attention from regulators, regardless of whether or not your employee swears that he or she is a medical aesthetician. If you distribute advertising materials using these titles, whether online or via other channels, your chances of being investigated are better still.

If a practice is found to be in violation of state regulations regarding medical advertising, it can incur severe financial penalties, and its physicians may even be subject to the suspension or revocation of their licenses. Regulatory agencies take issues such as these—which can rise to the level of “practicing medicine without a license”—extremely seriously.

The bottom line for owners and operators of medical aesthetic practices is that their advertising is under a great deal of scrutiny—far more than they may think. The requirements for medical advertising vary from state to state, so it is important to consult a health care attorney who is familiar with the regulations that govern medical advertising in your state before launching a marketing campaign in order to learn what is and is not legal. (Author’s note: AmSpa works with ByrdAdatto, a national law firm that focuses on medical aesthetic legalities, and as a member, you receive a discount off of your initial consultation, along with a number of other great benefits.)

How to Use Testimonials

If a patient of your medical aesthetic practice is over the moon about an experience there, you may be inclined to ask him or her to provide a testimonial that can be used for marketing purposes. However, there are limitations to the ways in which patient testimonials can be used in advertising for health care providers and, for reasons we’ve previously discussed, medical aesthetic practices must also abide by those rules.

Generally speaking, most states forbid hyperbolic testimonials that use statements such as, “Dr. Brown is the best doctor in the city!” As previously established, advertising for medical institutions must be based on facts, experience and credentials, so medical spa owners and operators must make sure that the testimonials they use are factually correct and address only the customer’s experience with the practice he or she is endorsing.

It is also important that you obtain proper consent from your patients before you post or distribute their testimonials. Even though the patients’ participation may seem to represent tacit consent, you must still go through proper channels to make sure that you are not opening yourself up to patient privacy issues. After all, acknowledging that a patient enjoyed a visit to your facility intrinsically reveals that he or she is your patient, which is a HIPAA violation. Again, speak with a knowledgeable health care attorney to learn what you are required to do to remain compliant when using testimonials.

Mind Your Business Partners

If a medical aesthetic practice is marketing its services via deal websites such as Groupon (which is of questionable legality in the first place—again, consult with your health care attorney before launching such a campaign to determine if it is allowed in your state), it should make sure that everything posted on those sites and disseminated via email by those outlets conforms to the rules of health care advertising previously discussed. These sites sometimes create their own copy and distribute it without running it by the client first. Regardless of whether or not it produced the copy, your practice would be the one facing blowback from state regulatory agencies, so make sure that you see everything associated with your practice before it is posted or sent.

Don’t Offer Incentives for Referrals

A medical spa operator may be inclined to create a promotion that offers, say, 50% off a Restylane treatment if you refer a friend to the practice. Although it might be perfectly fine for a salon or a traditional spa to offer such a deal on a facial, a medical practice making such an offer is essentially telling the world that it is giving monetary value for referrals, which is potentially a direct violation of local anti-kickback or patient solicitation statutes. Laws regarding kickbacks vary from state to state, but most states with powerful, influential medical boards consider such promotions to represent kickbacks. For the same reason, it’s generally a bad idea to offer gift cards in exchange for referrals.

Putting Your Best Foot Forward

Medical aesthetic practices must use a great deal of caution when conducting marketing campaigns. If a medical spa’s ad campaign is properly executed, it can be very effective; however, the practice must be very careful about what it says and what its patients say about it so that it does not run afoul of the strict statutes and regulations that govern medical advertising.

For legal updates and business best practices delivered straight to your inbox, subscribe to AmSpa’s email newsletter. For more information on how AmSpa can help your practice operate legally and profitably, contact us online or call us at 312-981-0993.

Tags:  Business and Financials  Med Spa Law  Med Spa Trends 

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The Secret Weapon That Will Explode Your Medical Spa Sales

Posted By Administration, Wednesday, December 18, 2019

medical spa receptionist

By Terri Ross, Terri Ross Consulting

As a leading sales training expert in the aesthetic industry with vast experience as a medical device sales director managing successful, peak performance teams and generating upwards of $20 million in revenue, one of the questions I get asked most frequently when I conduct staff trainings and seminars across the country is, “Terri, what is the number one thing we can do to increase our practice’s revenue?”

Can you guess what it is? Increasing pricing? Cramming in more patients per day? Shortening your consultation allotted time? Selling more expensive product lines or adding more retail products? Hiring more staff?

Those are usually the guesses I hear when I’m out speaking on expert panels at industry events or conducting onsite sales training in cosmetic surgery practices and medical spas around the country.

However, investing in powerful sales training for your team is the most overlooked strategy to increase your practice’s revenue, conversion rates and retention rates—whether you are in the process of launching your practice or are wanting to scale your current practice.

Understanding the Patient Journey

Sales and customer service are at the core of any successful business. The aesthetics patient is smart, savvy, educated and has a lot of choices when choosing one practice over another. Having a well-trained, knowledgeable and professional team is the difference between “good” and “great.”

It is critical to understand the importance of the patient journey and how each phase represents a distinct opportunity to provide high-quality patient care and ensure a positive, memorable customer service experience.

Approximately 52% of patient leads come from finding your website online, 25% are referrals from other patients, and the other 25% come from social media, other referring sites, other physicians or paid advertising.

A patient’s first point of contact with your practice is the initial phone call. This is your first and probably most important opportunity to make a great first impression.

Here are some questions to consider when evaluating how your staff is answering phone calls:

  • What kind of tone and attitude are they conveying with their voices?
  • Are they knowledgeable? Can they answer all of a prospective patient’s questions?
  • How well-trained are your team members on all procedures you perform and the products you use?
  • Can your staff easily explain why your practice stands out from the competition? In other words, can they answer “Why choose us?”
  • How solution-focused is your staff and how well-versed are they on the outcomes and benefits of each procedure?
  • Can your staff confidently navigate questions regarding pricing and potential objections?
  • Can they engage in dialogue to ask questions, rather than simply answering with a yes or no?
  • Are they making sure all of the prospects’ questions are answered?
  • Are they engaging in active/intuitive listening—hearing potential concerns behind the surface question?
  • Are they offering to schedule a consultation appointment to every caller?
  • What is their conversion rate for turning phone leads into consultation appointments?

I’ve created a free e-book resource that specifically focuses on this subject. Click here to download your free copy of The 13 Critical Components of a Successful Phone Call. As always, feel free to reach out if you have any questions or would like to set up a strategy session with me on this critical aspect of the art of sales.

Scheduling a Consultation

The goal of each patient inquiry should end with a call to action. Potential clients want to know the next step to take, even if they don’t verbalize that. Your team should always offer a clear path and call to action to schedule an appointment for a consultation.

The initial phone call is critical to book a consultation, which is an opportunity to convert a patient to a paying procedure.

Here are some questions for evaluating your staff’s ability to capture all the relevant information needed:

  • Are they gathering complete patient information, including name, referral source, best contact information, email, phone number, procedures they are interested in, address, zip code, date of birth, gender, concerns or any specific notes?
  • Are they following up with appointment reminders via text and phone calls?
  • Do they explain your cancellation policy and fee?
  • Are they taking credit card information to keep on file to reduce no-show rates?

If you are like most physicians, you are so busy working in your practice and using your gifts to perform highly skilled procedures that you may often overlook the critical component of working on your practice and training your front office sales team.

That is why it is vital to give your own practice a checkup. Scheduling one to three more patients a day for consultations could translate into $50,000 to $100,000 more a month.

Isn’t that worth the investment in sales training?

Even if your practice has not launched yet, now is the time to invest in expert sales training to start out on the right track.

Your front office team can easily be trained to be your most efficient, revenue-generating sales force, and as a clinical provider, your consultations can improve drastically for a better patient experience.

Remember, I’m here to help you make your practice thrive. If you would like to schedule a call to see how expert sales training can generate more revenue for your practice, please fill out this discovery questionnaire, and I will be happy to connect with you.

Terri Ross brings more than 20 years of sales and management experience to the field, having worked with leading-edge medical device companies such as Zeltiq, Medicis, EMD Serono, Merck Schering Plough and Indigo Medical, a surgical division of Johnson.

Ross’ vast knowledge and experience as a sales director managing upwards of $20M in revenue and successful teams has allowed her to become a renowned plastic surgery management consultant helping aesthetic practices thrive.

To optimize revenues and business performance, Ross’ practice management consulting services help physicians evaluate practice processes including, but not limited to, overall-operating efficiencies, staff skill assessment, customer service and operating efficiency strategies. The goal is to develop a comprehensive plan of action to improve productivity, quality, efficiency and return on investment.

Tags:  Business and Financials  Med Spa Trends  Terri Ross Consulting 

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Learn from the Top 100 Injectors in America

Posted By Eric Atienza, Monday, December 16, 2019
Updated: Monday, December 16, 2019

botox injection

This year’s list of the Top 100 Best Injectors in America is out, and several of them are ready to share tips on how they became the best at The Medical Spa Show 2020. From January 31 – February 2, 2020, learn how industry-leading injectors built their practices. See the full agenda here!

George Baxter-Holder, ARNP, DNP, CANS, SkinSpirit, Bellevue, WA

PANEL: Up and Coming Treatment Trends Panel: The Good, the Bad and the Ugly

Track: Clinical Practice and Technique: Today's Clinical Landscape

Friday, January 31, 1:40 – 2:40pm

PANEL: The All-Star Injector Panel: Tips and Tricks from Today's Top Injectors

Track: Clinical Practice and Technique: Injectables

Saturday, February 1, 9 – 10am

Patrick Bitter Jr., MD, Advanced Aesthetic Dermatology, Los Gatos, CA

Staying Competitive in the Era of Discounts

Track: The Business of Med Spas
Friday, January 31, 1:05 – 1:30pm

Top Trends in Laser and Light Therapy

Track: Clinical Practice and Technique: Today's Clinical Landscape
Friday, January 31, 4:25 – 4:50pm

PANEL: The All-Star Injector Panel: Tips and Tricks from Today's Top Injectors

Track: Clinical Practice and Technique: Injectables
Saturday, February 1, 9 – 10am

“Botox Josh” Davis, RN, BSN, Whisper Wood, Brentwood, TN

Community Over Competition: We’re Stronger Together

Track: Marketing & Social Media
Friday, January 31, 2:15 – 2:40pm

PANEL: The Freshest Tips and Tricks for Social Media Today

Track: Marketing & Social Media
Saturday, February 1, 3:55 – 4:55pm

PANEL: Social Media 101

Track: Social Media 101
Sunday, February 2, 10 – 11am

Hear more from Botox Josh!
Medical Spa Insider Episode 17: Looking Beyond the Bottom Line (With Profitable Results)

Kay Durairaj, MD, FACS, Beauty by Dr. Kay, Pasadena, CA

Lift, Definition, and Collagen Stimulation with Radiesse

Track: Sponsored Education
Saturday, February 1, 10:45 – 11:10am

Kelly Gibbs, RN, BSN, CANS, Beauty Co., Raleigh, NC

The Perfect Lips with Demo

Track: Clinical Practice and Technique: Injectables
Saturday, February 1, 1:50 – 2:50pm

PANEL: The Freshest Tips and Tricks for Social Media Today

Track: Marketing & Social Media
Saturday, February 1, 3:55 – 4:55pm

How Do you Become a Social Media Influencer in Your Community?

Track: Social Media 101
Sunday, February 2, 8 – 8:25am

PANEL: Social Media 101

Track: Social Media 101
Sunday, February 2, 10 – 11am

Hear more from Gibbs!
Medical Spa Insider Episode 24: When You’re Offered a Seat on the Rocket Ship

Kevin Harrington, MSN, APRN, FNP-C, Face-Time Aesthetics, Fruitland Park, FL

PANEL: Up and Coming Treatment Trends Panel: The Good, the Bad and the Ugly

Track: Clinical Practice and Technique: Today's Clinical Landscape
Friday, January 31, 1:40 – 2:40pm

Shelby Miller, DNP, FNP-C, Ruma Aesthetics, Sandy, UT

How I Made $1 Million in Revenue from Instagram

Track: Marketing & Social Media
Saturday, February 1, 2:25 – 2:50pm

PANEL: The Freshest Tips and Tricks for Social Media Today

Track: Marketing & Social Media
Saturday, February 1, 3:55 – 4:55pm

Hear more from Miller
Medical Spa Insider Episode 35: How to Make $1.5 million in Revenue from Instagram

Anil Rajani, MD, Rajani MD, Portland, OR

The Latest on PRP and PRF Procedures

Track: Clinical Practice and Technique: Rejuvenating Technologies
Saturday, February 1, 1:15 – 1:40pm

Jonathan Sykes, MD, The Roxbury Institute, Beverly Hills, CA

Live Cadaver Training: Facial Anatomy Course

Track: Post-show Education
Sunday, February 2, 12:30 – 3:30pm

Steven F. Weiner, MD, The Aesthetic Clinique, Santa Rosa Beach, FL

Learn how Dr. Weiner turned IV Therapy into a marketing engine for his medical spa.

Building and Operating a Successful IV Therapy Practice

Track: Clinical Practice and Technique: Rejuvenating Technologies
Brittany Brock, PA-C, and Nikki Willmott, RN, The Aesthetic Clinique
Saturday, February 1, 9:35 – 10am

Hear more from Dr. Weiner.

Medical Spa Insider Episode 34: Plastic Surgeon Turned Med Spa Owner Reflects on Success

Click here to see the full list of Top 100 Injectors.

The Medical Spa Show 2020 features five simultaneous tracks of education showcasing clinical technique, med spa laws, business best-practices and marketing how-tos to help you become the best in the industry. More than 90% of past Medical Spa Show attendees would recommend the conference to their colleagues, so find out what hundreds of your peers can’t stop talking about!

Register today!


Sheila Nazarian, MD, MMM, Spa26, Beverly Hills, CA
Medical Spa Insider Episode 13: Dr. Sheila Nazarian on Her Goals, Her Motivations, and Her History in Aesthetic Medicine

Tags:  Med Spa Events  The Medical Spa Show 2020 

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Legal Considerations for Medical Weight Loss Clinics

Posted By Administration, Friday, December 13, 2019


By Michael S. Byrd, JD, Partner, ByrdAdatto

The obesity rate continues to grow, and so too does the competitive world of weight loss centers. The ability to prescribe medication is what makes medical weight loss clinics stand out in this crowded field. Along with pharmacotherapy, these clinics offer other non-surgical solutions, ranging from menu and exercise planning to counseling, all under the supervision of a physician. While these clinics can be lucrative, health care entrepreneurs should be aware of certain regulations before opening one.

In Texas, California and several other states, the “corporate practice of medicine” rule prohibits lay people or lay entities from employing physicians or offering professional medical services. Simply put, doctors can practice medicine; lay people cannot. The rule is meant to protect the general public from business owners who are more interested in income than quality health care, and its violation can lead to a felony conviction. As the wellness sector expands, the line between business and medicine begins to blur. But to be clear, even non-invasive procedures offered at a medical weight loss center can be considered the practice of medicine, and as such, this prohibition applies.

This begs the question: How are entrepreneurs and other non-physician providers able to own medical weight loss clinics? The answer can be found through a tried and true legal model used in the health care industry: the management services organization (MSO) model. Click here to read a previous post that sheds light on the prevalence and basic inner workings of the MSO model.

Staffing is another major consideration in establishing and owning a weight loss clinic. Each state has differing guidelines that delineate who can provide certain medical services. For example, in some states it is illegal for an unlicensed person to administer an IV or a CoolSculpting treatment, a common practice at a weight loss clinic. But not all states specify what kind of licensing and training are required for someone who provides elective, non-invasive services. This absence can lead to confusion. Some states go in the opposite direction and provide additional guidance on supervision and training. In Texas, for example, the Texas Administrative Code, Section 193.17, “Nonsurgical Medical Cosmetic Procedures,” specifies those parameters. However, even this section does not address all medical procedures that can be found in a medical weight loss clinic.

Medical weight loss clinics provide a necessary service within a multi-billion-dollar industry. However, these businesses are subject to stricter guidelines than the typical weight loss center. As with any health care-related business, certain regulations need to be observed.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

With his background as both a litigator and transactional attorney, Michael Byrd brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2018) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016, 2017, 2018). He routinely lectures at continuing medical education seminars on the various business and legal issues that medical professionals face.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Ownership 

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Can Your Medical Spa Withstand the Wave of Website Inaccessibility Lawsuits?

Posted By Administration, Monday, December 9, 2019

website on several devices

By Kita McCray, JD, ByrdAdatto

The Beach Boys believed, “If everybody had an ocean, across the USA, then everybody’d be surfin’, like Californi-a.” Fast forward 50 years, there has definitely been a rising tide of enthusiasm about surfing, but it’s not the enjoyable surfing experience the Beach Boys crooned about.

Recently, there has been a rise in frivolous “website surf-by lawsuits” alleging website inaccessibility violations based on Title III of the American with Disabilities Act (ADA). Title III prohibits discrimination on the basis of disability in places of public accommodation, requiring that such places be accessible to those with disabilities. Surf-by lawsuits arise when individuals systematically surf the internet looking for vulnerable business websites that are inaccessible or not fully accessible to people with disabilities. The individuals typically send a letter demanding settlement for the alleged violations in lieu of being taken to court, where the cost of litigation may be higher than payment of the settlement. Depending on the jurisdiction, website litigation settlements could range from $4,000 to $20,000.

Exacerbating the issue is an absence of formal government guidelines on ADA website compliance to instruct private businesses on how to ensure their websites comply. The absence of specific government guidelines or a legal consensus on how ADA compliance translates to the web, coupled with a cultural trend toward a more web-based marketplace, has left a wide berth for potential litigation. This loophole is why we counsel clients to be proactive and mitigate their risks by implementing a plan or hiring experts to make sure their website is ADA accessible.

For example, companies such as Crystal Clear Digital Marketing have been building and refining digital marketing tools and strategies to keep businesses profitable, including developing ADA-compliant add-on software, which provides a high level of coverage for its clients.

“Website accessibility standards are not set in stone, and the standards are ever-evolving. The standard for today may not be the standard for tomorrow,” said Joe Amaral, chief operating officer for Crystal Clear Digital Marketing. “This is why compliance requires ongoing monitoring. ADA website compliance is a combination of technology and human evaluation, with the human element constantly reviewing current standards and making updates as necessary.”

Businesses also could mitigate their risks by reviewing the recommendations offered in the Web Content Accessibility Guidelines, or WCAG 2.0 AA, and develop a plan to integrate these recommendations into their existing website accessibility policy.

Until this wave of surf-by lawsuits alleging website inaccessibility violations breaks, no surfboard can navigate these tricky waters. Hire an expert and legal counsel to help you lessen the risk of your company being targeted by these surf-by plaintiffs and their legal representatives, because it’s not a matter of if a plaintiff comes across your website—it’s a matter of when. And when they do, you will get sued if your site is found to not be compliant.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

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:  ByrdAdatto  Med Spa Law 

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AmSpa provides legal, compliance, and business resources for medical spas and medical aesthetic practices.

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