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Texas Publishes Proposed Changes to Delegation Rule §193.17

Posted By Administration, Monday, July 8, 2019

texas u.s. flags

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

The July 5 issue of Texas Register contains proposed changes to the Nonsurgical Medical Cosmetic Procedures delegation rule known as Rule §193.17 of the Texas Administrative Code. We previously covered the stakeholder meeting where this and an alternative proposal were introduced. The board approved the publication of this proposal at its last meeting, as it had not received any negative comments about it. This publication is the next step in formally adopting this change.

To briefly review the issue, this proposed change adds a notice provision to the current delegation rules. Every facility that provides nonsurgical medical cosmetic procedures will now be required to post a notice in each public area and treatment room. The notice needs to provide the name and license number of the physician who delegates the procedures, as well as information about how to file a complaint with the medical board. The form and content of this notice must follow the medical board’s rules contained in Rule §178, and specifically the approved formats found in §178.3.

The proposed changes can be viewed starting on page 63 of the most recent issue of the Texas Register. Also of note in this issue is the repeal of rule §193.8 on standing delegation orders. This change is designed to conform to a recent law change that requires monthly meetings between physicians and physician assistants or advanced practice registered nurses.

With the official publication of these changes, the earliest they could be formally adopted is August 4, 2019. There may be a public hearing to solicit comments; however, none is scheduled at this time. If you wish to make a comment or get more information about these changes, you can contact Texas Medical Board General Counsel Scott Freshour at 512.305.7016.

Tags:  Med Spa Law  Med Spa Trends 

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The Legalities of Body Sculpting

Posted By Administration, Tuesday, July 2, 2019

body sculpting

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

Body sculpting is one of the truly hot trends in the medical aesthetic industry. It is administered by applying either extreme cold or extreme heat to fat, which causes the fat to break down and die, after which it exits the body via natural processes. It has proven to be very effective in removing relatively small fat deposits from hard-to-address areas of the body. CoolSculpting from Allergan is the industry leader for this type of therapy, so much so that its name has became virtually synonymous with cryolipolysis, the “cold” variant of this treatment. SculpSure from Cynosure is another popular body sculpting treatment—it uses lasers to kill fatty tissue. In addition, several other companies now provide similar products and services.

Despite the popularity of these treatments, though, some questions still exist regarding who can perform them. Cryolipolysis treatments, especially, are somewhat tricky in this regard, because they don’t use light-emitting devices or lasers, so it falls into a grey area where a lot of the existing laser statutes don’t cover it directly. Cryolipolysis equipment is not a light-emitting device, a laser, or an ultrasound—it simply uses extremely cold temperatures, and the manner by which these temperatures are produced is typically not regulated.

As such, it has been argued that, because cryolipolysis does not fall within the scope of the regulations that are currently on the books, it is therefore not the practice of medicine. If this is the case, anybody could perform these treatments, provided they were properly trained to do so, and the practice would not need to conduct a face-to-face exam with a licensed medical professional prior to the procedure. In addition, it would obviate certain issues related to payment and processing.

The counterargument to this is that generally, medical boards find that medical treatment occurs when an ailment is diagnosed and living tissue is impacted; every state’s regulations are slightly different, but typically, this is a baseline that is observed practically everywhere, particularly as it relates to aesthetic treatments. It cannot reasonably be argued that cryolipolysis treatment doesn’t meet both of these conditions—an unwanted fat deposit is observed, treated with extreme cold in order to destroy it, and then expelled from the body. This clearly affects living tissue and so, from a legal standpoint, it should be considered a medical treatment. As such, it requires a face-to-face exam and patient history, and it must be performed by a licensed medical professional, or delegated to a nurse or technician who is properly trained and supervised.

It is my belief that if this was ever presented to a medical board—it hasn’t been yet, but I’m sure it will be someday—the board would find, without question, that cryolipolysis is the practice of medicine. Medical aesthetic practices that don’t use the same procedures for cryolipolysis that they would for laser treatments are taking a risk, because when you get right down to it, everything that is true about laser treatments is true about cryolipolysis when it comes to the way it affects living tissue.

However, AmSpa is not aware of any laws that specifically address cryolipolysis for body-sculpting purposes and, until there are—or until an influential medical board rules on the matter—the grey area will remain at least somewhat grey. It is recommended that you speak to an experienced local healthcare attorney regarding his or her interpretation of the regulations in your state that could be applied to this treatment. (Author’s note: AmSpa works with a national law firm that focuses on medical aesthetic legalities and, as a member, along with a number of other great benefits, you receive a discount off of your initial consultation. Click here to learn more.)

However, we at AmSpa and ByrdAdatto firmly believe that cryolipolysis falls within the practice of medicine, and that any practice providing this treatment should observe the same procedures regarding patient care that it would with any other medical treatment.

Tags:  Med Spa Law  Med Spa Trends 

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MSOs: Your Path to Profit Optimization

Posted By Administration, Friday, June 28, 2019

doctor businessperson partnership

By Nicole Chiaramonte, CEO, TWG Consulting Corp.; founder, Synergy MedAesthetics; and aesthetic industry investor

The skyrocketing demand for aesthetic services in the U.S. has created a tremendous opportunity for business experts, entrepreneurs and investors. In an industry that until recently was run exclusively by physicians, the mainstreaming of management service organization (MSO) partnerships allows doctors to partner with entrepreneurs and benefit from their business expertise while they focus on the medicine.

With the advent of selfies, the Kardashian phenomenon and social media, women and men of all ages are flocking to spend money to look their best. The current medical establishment is not necessarily ready to handle this in a way that is beneficial for them, their employees and their patients. This is where MSO partnerships have allowed for a win-win-win in the aesthetic world.

An MSO allows investors and business experts to partner with a physician in a legal manner, thus not violating the corporate practice of medicine. These partnerships have proven to be profitable for all involved when properly executed. To understand the benefits of MSO partnerships for all parties, one must first understand the unique benefits and skillset everyone brings to the table and, just as important, what their responsibilities are in such arrangements.

Entrepreneurs

As an investor in the aesthetic industry, you will provide your time, investment capital and business expertise to the partnership. This may include a love for spreadsheets and a “Beautiful Mind” ability to read into the deeper layers of a profit and loss statement, balance sheet or statement of cash flow to identify unnecessary losses and quickly increase profit margins. These skills are what you bring to the table and why you are needed in this industry.

But your education has just begun. To be truly successful in this venture, you will need to gain a comprehensive understanding of aesthetic procedures—not only what they are and what they do, but also why they work. You will learn more than you ever thought you would know about the body’s healing systems, skin health, facial anatomy and more. Attend every practitioner training you are allowed to audit, conduct research online, and understand the competitive products, technologies and services. You will need to know them all this well enough to effectively market the practice, train administrative staff and answer patient questions.

When negotiating percentages of ownership in an MSO with a physician, remember to honor the dedicated time and expense required of your partner’s medical degree, as well as the responsibility he or she takes on with every treatment performed. Your active hours contributed to the operation may be significantly more when compared in the short-term, but his or her ongoing risk is real.

Physicians

It is common for doctors to feel the risk to their license is too great to enter into an MSO—they resist the idea of relinquishing a percentage of profit or determine they can best run a practice on their own. In my experience, 100% of the time, a physician enjoys more income from a partnership than he or she did prior to partnering into an MSO. In addition, physicians experience considerably less stress, aggravation and demands on their time when their partners are able to assume responsibility and management of staffing, human resources, inventory, accounting, payroll, patient management, and advertising and marketing.

Partnering with someone who has gone to the lengths necessary to know your industry, proper protocols, SOPs and standing orders is key for physicians considering MSO partnerships or medical directorships. Your partner should put the safety of your license above all else. If you have the right business partner, he or she may inform you about new clinical studies, FDA approvals and technique developments before you hear about them. This is especially necessary in an environment where you are a non-practicing aesthetic medical director who has delegated to onsite mid-levels (nurse practitioners and/or physician assistants).

Once a partnership is in place and responsibilities and parameters are set, it is time to get to work on profit optimization. In my experience of owning 20% to 85% interest in 12 MSOs, the following areas are the first places I audit, whether the practice is in operation or brand new.

  1. Back bar/treatment room materials. This includes everything from Hydrafacial MD products to Botox and machine consumables. How often are you checking for inventory loss or overuse of product that throws your margins off by up to 70%?
  2. Capital purchases. If you are paying list price for new machines, this can take a huge bite out of your profits, benefiting no one but your sales rep.
  3. Staffing. You must make sure you have proper hours, compensation levels and adequate coverage with the necessary practitioners.
  4. Advertising and marketing. From website development to ongoing social media marketing, is your practice paying a premium because you are deemed “medical?”

In short, aesthetic practice profitability is illusive to some and an exact science to others. MSO partnerships are legal, profitable ways to operate an aesthetic practice to the benefit and delight of all involved.

Tags:  Business and Financials  Guest Post  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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FDA Makes Statement on Medical Device Reporting Changes

Posted By Administration, Tuesday, June 25, 2019

device

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

On June 21, the U.S. Food and Drug Administration (FDA) announced several changes meant to improve and streamline its reporting requirements for medical devices. This likely will be a welcome change for device manufacturers and hopefully reduce their compliance burden. In the press release, which you can click here to read, Jeffrey E. Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, discusses three major changes to the agency’s strategy for tracking and monitoring medical device adverse events. Under current FDA rules, device manufacturers are required to submit a medical device report (MDR) within 30 days if the use of a medical device results in serious injury or death. In order to monitor trends, FDA has implemented several voluntary reporting processes for manufacturers to follow for device malfunctions that do not result in serious injury or death.

The agency announced the discontinuation of one such voluntary reporting process. The Alternative Summary Reporting (ASR) Program was implemented in 1997 and allowed manufacturers that were granted exemptions on particular devices to submit batched reporting for devices that had certain well-known risks. This program included exemptions for dental implants, implantable defibrillators and pacemaker electrodes, totaling 108 such devices in all. This program had been being phased out since 2017, first through the institution of a supplementary reporting process and now with the full discontinuation.

It will be replaced by a new program known as the Voluntary Malfunction Summary Reporting (VMSR) Program, which allows manufactures to report incidents quarterly. However, this is only for minor incidents—serious injury and death reports are still required within 30 days. One of the goals of this program is to make the reported data compatible with FDA’s information database, known as MAUDE; the ASR Program’s lack of compatibility with MAUDE was one of its shortcomings. FDA hopes to streamline MAUDE and make its data more user-friendly and accessible, all with the aim of monitoring and catching defective or problematic devices as quickly as possible.

In addition, FDA is instituting a new data monitoring system that can analyze data continuously and automatically using algorithms. The system is called the National Evaluation System for Health Technology (NEST), and it has been in development since 2012. It utilizes large sets of data tied to each device’s unique identification codes. FDA hopes that it will be able to better protect patients by identifying trends and issues earlier than a human would be able to.

FDA is making these changes in order to better protect the public and the users of these devices. The changes should also make it easier for device manufacturers to submit their required reports. And if all of these FDA acronyms make your head spin, you should consider attending one of AmSpa’s Medical Spa & Aesthetic Boot Camps. There, you’ll learn how to set your business apart from your competitors, including the latest in technology and the newest devices.

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

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This Name’s Taken: The Importance of Trademark Law in Your Practice

Posted By Administration, Monday, June 24, 2019

trademark law

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

A medical aesthetic practice’s brand is among its most valuable assets. When your patients think of your facility, your brand is the first thing that enters their minds. Therefore, it is vital that you take the utmost care in creating and protecting your brand, and obtaining trademark protection for it is an important part of this process. Whether you are already operating a practice or are planning to open one in the near future, this is important information to have. Here is a quick primer.

In on the Ground Floor

The American Medical Spa Association (AmSpa) recommends that before opening, dermatology practices, cosmetic surgical practices, and medical spas do a trademark search for the name that they plan on using. This isn’t necessarily important if you are a plastic surgeon who plans on using his or her name for the practice (for example, Dr. Meredith Anderson’s Plastic Surgery), but if your practice is a medical spa that is planning to use a name such as, say, Effervescence Medical Spa, you need to make sure that this name or a confusing similar name is not already in use.

“[Businesses] should engage an attorney experienced with trademark law to perform a searches to determine whether there may be any conflicts before they even hire a graphic designer to develop a logo or business name,” says Jim Stanford, partner at ByrdAdatto, a business and health care law firm based in Dallas. “I’ve run into problems so many times where a company has spent all sorts of money and resources developing its name and logo only to find out that there’s a conflicting use out there and they have to change everything. This typically occurs when they receive a cease and desist letter from the other party’s attorney or when they are seeking trademark registration.”

A properly conducted trademark search is a much more labor-intensive process than one might imagine.

“Typically, we hire an outside company such as Corsearch, and they’ll provide a comprehensive report that’s usually 200-300 pages long,” Stanford explains. “We review the various uses in the report that might be similar or conflicting with the proposed mark. If there aren’t any conflicts at all or registration appears feasible subject to potential challenges that are acceptable to the client, we’ll proceed with the application process. But if it looks like there might be a problem, we point that out to the client and discuss the risks, and sometimes we advise the client not to use their proposed trademark and search for another.”

The attorney may give the client the go-ahead to submit an application, but that doesn’t mean that the process is over. First, the attorney and the client must decide what elements of the branding they need to protect.

“The application part is somewhat administrative—we need to identify the goods and services that are associated with the mark so we can determine what classes they go into, prepare a description of the goods or services, and put the application together,” Stanford says. “If the client has a logo or design element to the mark in addition to the word mark itself, its often advisable to seek registration of both through separate applications to obtain broader protection.”

After the application is completed and submitted, the waiting game begins.

“Once the application is finalized, prosecution of the application, that is, seeking registration with the U.S. Patent and Trademark Office (USPTO) is a pretty lengthy process,” Stanford says. “We’re not going to hear back from the USPTO for at least four months. From there, if there are any issues or conflicts, we have to address them with the USPTO examining attorney, and there may be some back and forth. From my experience, the quickest a trademark may be registered with the USPTO is probably 9-10 months or so—it typically takes close to a year or longer to finally get it registered, if you don’t have any major issues.”

The total cost of the trademark process can vary greatly from case to case, but generally speaking, it is a somewhat notable financial commitment, especially since the medical spa or practice is just beginning its journey.

“The more classes you have, the more the initial cost is,” Stanford says. “The initial filing and search and clearance is typically $2,000-3,000, on average, but it’s much better to spend this money up front than to have to deal with potential conflicts or lawsuits in the future that will cost tremendous amount more to resolve.”

A Question of Complexity

Stanford recommends that those who seek trademark protection for their medical spa or medical practice’s name and logo make sure that it meets certain conditions before the filing process begins.

“The client [should do] their best to pick something that is not descriptive of what they’re doing, because that hurts the value of a mark,” he says. “The marketing world and clients in general prefer to select names and trademarks that either say or describe exactly what they’re offering and, from a trademark law perspective, this weakens the trademark or ability to get it registered as a trademark. [For example], ‘Star Medical Spa and Skin Care Center’—would be a challenge and likely would not get registered on the principal register as a trademark because it’s descriptive of the services that are associated with the mark and the only non-descriptive element is ‘Star’. The more the mark is arbitrary or at least only suggestive of the goods or services associated with the mark, the stronger the trademark will be, and the better chance of obtaining registration. Assuming there were no conflicting uses, ‘Effervescence’ as the sole trademark and only word in any logo or design mark would be a much better mark. When you put your sign on your wall or launch your website, you can always  use your trademark next to the words ‘medical spa’, for example, but they should not be part of the trademark itself.”

Investigating Infringement

Making sure that your practice’s brand isn’t already in use is important because the penalties for trademark or trade name infringement can be severe.

“If another party has a trademark registered with the USPTO and your mark is infringing, you have constructive notice, even if you didn’t actually know about the other mark, and you could potentially get hit with the other party’s actual damages, a reasonable royalty, and damages equal to your profits,” Stanford said. “Including possible treble damages if your infringement was determined to be willful--it could be a nightmare and it could cost you  your business.”

A trademark violation could lead to major financial problems for a medical aesthetic business. Even if you’ve registered a trademark with your state’s department of business services (which is usually associated with the secretary of state’s office), you may still be infringing on a national mark, which could lead to major problems.

Typically, however, the party owing the registered trademark will send a cease-and-desist letter and you should have the opportunity to negotiate a settlement. Although this certainly is preferable to court, the cost can still be substantial.

“The legal fees in just settling that situation could easily be $10,000-30,000, depending on how much it goes back and forth,” Stanford says. “In any potential dispute, the legal fees add up very quickly.”

The winners of these disputes tend to be the entity with the deeper pockets, even if they don’t have a legal position that ultimately would be successful in court—they simply want to cut out competition. If your medical practice is just starting out or establishing itself in the industry, chances are that won’t be you.

“I’ve had matters where I didn’t believe our client was infringing, but the party on the other side had more than enough money to pound our client into the dirt and we had to concede as our clientcouldn’t afford or at least justify the legal fees to fight it,” Stanford says.

A business can sink tens of thousands of dollars into marketing, product development, and branding, only to have to choose whether to redo all their branding because they’ve been hit with a trademark claim, or spend at least as much money on attorneys to fight an infringement claim, even though they have a fairly decent shot of winning in the end. The enormous expense associated with court cases such as these underscores the importance of making sure that your trademark protection is squared away as soon as possible.

“You spend $5,000 up front to try to make sure you do it right to avoid $50,000 to change your mark once you find out you have a conflict,” Stanford states.

Making Your Mark

One of the things ByrdAdatto always tells its clients at the beginning is that, if there is a specific name that you want to use, a trademark search should be done and, if advisable based on the situation, a trademark application should be filed. As the medical aesthetic industry grows, brands expand, and more and more large franchises emerge with a great deal of financial backing, it is simply not smart to operate without properly vetted trademark protection. Thanks to the Internet, it is easy to find a business that’s violating a company’s trademark, and you’d better believe that company’s lawyers are actively looking for just that opportunity. You might think you have the greatest name in the world, but if you can’t actually use it, it will do you far more harm than good.

Tags:  Business and Financials  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Join AmSpa at the Atlanta Medical Spa & Aesthetic Boot Camp

Posted By Administration, Friday, June 21, 2019

loews atlanta

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

Starting next Saturday, June 29, AmSpa will host its Atlanta Medical Spa & Aesthetic Boot Camp at the Loews Atlanta Hotel. We’re extremely excited for the opportunity to help medical aesthetic professionals develop their practices, and we can’t wait to visit Atlanta again. There’s still time to register for the event—just click here to sign up. Here is a quick overview of the program:

Saturday, June 29

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

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 10:45 – 11:45 a.m.: The Lessons, presented by Louis Frisina—Every medical spa is different, but the successful ones share several common traits. In this session, Business Strategy Consultant Louis Frisina discusses the qualities that are typically found in practices that bring in a significant amount of revenue.
  • 12:45 – 1:30 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), James David Brown (Environ Skincare), Helen Haynes (Bellus Medical) and a representative from Galderma—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Jay D. Reyero (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4:15 – 5 p.m.: The Treatments, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and find out how to best determine which treatments are right for you based on the state of your practice.
  • 5 – 6 p.m.: The Digital Marketing Ecosystem, presented by Tim Sawyer (Crystal Clear Digital Marketing)—Find out how to effectively spread the word about your medical aesthetic practice and how best to determine what’s working and what’s not. Your practice’s digital presence is more important than ever before, and curating it should be a top priority.

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

Sunday, June 30

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

  • 8:30 – 9 a.m.: Anatomy of a $5-Million Med Spa, presented by Alex Thiersch (AmSpa)—Have you ever wondered what the difference is between your medical spa and one that’s mega-successful? It might be less significant than you think. This presentation will show what a $5-million med spa is doing right—and what you might be doing wrong.
  • 9 – 10 a.m.: The Financials, presented by Bryan Durocher (Durocher Enterprises)—At the end of the day, the money you’re bringing in is the most important measure of your practice’s success. This presentation will, among other things, demonstrate how to properly develop a budget and use metrics to determine your med spa’s strengths and weaknesses.
  • 10:30 – 11:30 a.m.: The Long-term Revenue, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—Simply being successful isn’t enough for a medical aesthetic practice; you have to know how to maintain and grow your success. In this session, Brandon and Jenny will show you how to build patient loyalty and move your business forward.
  • 11:30 a.m. – 12:15 p.m.: The Consultation, presented by Terri Ross (Terri Ross Consulting)—As the old saying goes, you never get a second chance to make a first impression. Learn how to put your best foot forward with effective patient consultations—and how to turn them into consistent business.
  • 1 – 2 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.
  • 2 – 3 p.m.: The Marketing Plan and Social Media, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—This session will help you determine how to most effectively market your medical aesthetic practice using both traditional methods and cutting-edge techniques.

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

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

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

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Botched Procedures: What Happens Next?

Posted By Administration, Monday, June 17, 2019

injection

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

If you are in practice long enough, you are going to have a bad outcome—it’s just a matter of time. I’ve never met a doctor who hasn’t been sued. No matter how careful you are, there is a very good chance that a bad outcome will occur on your watch. Sometimes it’s a side effect that occurs due to improper disclosure on consent forms or is not mentioned in the product manufacturer’s guidelines. However, people also make mistakes, and they may be held accountable for them. Regardless of the circumstances, understanding what to do when a bad outcome occurs on your watch will help your medical spa emerge from the situation more or less unscathed.

Keep Calm and Carry On

First and foremost, panicking and attempting to cover up the issue that led to the bad outcome is absolutely the worst thing a practice or physician can do. When people get in trouble for bad outcomes, it’s because they become defensive and try to blame the patient, as opposed to being proactive and taking steps to mitigate the possibility of further bad outcomes in the future.

Making sure your practitioners obtain properly executed informed consent is one way you can reduce your practice’s potential liability. This means that you need to make sure that all your consent forms are up to date and that a thorough dialogue with all patients regarding consent has occurred.

Informed consent is not a cure-all, however. Most medical malpractice attorneys will tell you that a signed, up-to-date consent form is something they have no problem dealing with. But at the very least, properly executed informed consent gives you a leg to stand on. It shows a certain amount of professionalism and conveys the notion that the practice acted in good faith. Additionally, make sure that your medical spa is thoroughly compliant with all state rules and regulations. This shows that you have created an infrastructure for safety and compliance at your practice.

A Matter of Respect

Moreover, studies indicate that if your medical spa is pleasant, empathetic, and responsive, and patients have a good experience, they will be much, much less likely to sue if a bad outcome takes place. The issues associated with bad outcomes don’t just start when the treatment occurs—they begin the moment a patient begins to interact with the medical spa.

Do your patients feel like they’re important, that they’re being respected, and that the practice is concerned with their well-being? If so, nine times out of 10, they are going to want to work with you to turn a bad outcome into a good one. Schedule a follow-up appointment as soon as possible, give them advice, and return their phone calls, e-mails, and texts right away. If you do this, these patients may actually become more loyal and say better things about your practice, because, generally speaking, people understand that things don’t always go as expected. They simply want the doctor and staff to listen to them, take responsibility, and do whatever they can to make it right.

Practices tend to run into problems with bad outcomes when they get defensive, blame the patient, and refuse to listen to the patient’s concerns. When this happens, an aggrieved patient is going to be far less inclined to work with you on a solution.

Problematic Patients

Of course, some patients simply can’t be reasoned with, and not engaging with these people in the first place is a key to avoiding complications related to bad outcomes. The medical aesthetic industry attracts more than its fair share of very passionate people, and most of the complications related to bad outcomes involve patients who are not responsive, don’t follow the guidelines given to them, or are just straight-up crazy. If you can avoid engaging with these patients, you can eliminate many of the problems associated with bad outcomes that you might otherwise encounter. Screen your patients thoroughly in order to determine if there are any red flags before you embark on a course of treatment.

If a problem will be solved by giving the customer a refund, it’s almost certainly worth it. However, if you do this, have your lawyer draw up a refund agreement that releases you of responsibility for the outcome in return for the refund. If a patient threatens to sue you, contact your lawyer immediately; even if it does turn out to be an idle threat, you have to take it seriously.

The Best Policy

More than anything else, you should be completely forthright and honest when dealing with a bad outcome. The cover-up is always worse than the crime. The more you contort your narrative to try to create a reality in which your practice doesn’t look so bad, the more problems you create for yourself. Tell your lawyer and your insurance carrier the truth about the situation, and they’ll do their best to recommend a viable course of action.

To learn more about the legalities that govern medical aesthetics, sign up to attend an AmSpa Boot Camp. At these events, attendees learn how to operate medical spas compliantly and profitably.

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

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Proposed Supervision Rule Change Creates Controversy at Texas Medical Board Stakeholders Meeting

Posted By Administration, Wednesday, June 12, 2019

physician supervision

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

Last week, the Texas Medical Board held a meeting to solicit feedback from stakeholders on possible changes to medical board rules that are in development. Representatives from AmSpa attended this meeting and had conversations with stakeholders and interested parties. The meeting generated some lively discussion regarding the changes, one of which was for Rule 193.17. This rule provides protocols for physician delegation of “nonsurgical medical cosmetic procedures,” which encompass most of the treatments offered in medical spas.

It is important to understand that this meeting was to discuss rules “in development” that have not been formally proposed or begun the official process of adoption. These developmental rules may change before being officially proposed—if they are officially proposed at all.

The development committee offered two versions of proposed changes for Rule 193.17. The primary proposed change would require offices that provide nonsurgical medical procedures to post a notice in the treatment rooms and lobby that includes the name and license of the delegating physician, as well as information for making complaints to the Board of Medicine.  The specific details of this notice are contained in the current Medical Board Rule 178.

An alternative proposal was also discussed, and it would make three additional changes:

  • Physicians would no longer be able to delegate to unlicensed persons;
  • A physician or midlevel would need to provide onsite supervision whenever procedures are delegated; and
  • The rule would explicitly state that these nonsurgical cosmetic medical procedures constitute the practice of medicine, and facilities providing them would need to be owned by a Texas licensed physician.

The alternative proposed rules generated the most discussion from the stakeholders present. A number of different parties raised concerns and complaints over all three of the proposed amendments. In an email, the Texas Medical Board relayed that these alternative proposed rules would be held for further consideration and possible revision. It assured attendees that it would hold a future stakeholder meeting if these changes were considered again. At present, however, the board is not moving forward to the next stage of the revision process.

The Medical Board also informed attendees that the primary proposal regarding the notice requirements had not received any negative feedback; as such, this change will be presented to the full Medical Board for consideration. The board will consider this change at its June 14 meeting, and if they approve the change, a 30-day public comment period before formal adoption will begin.

Click here to view the present version of the changes that will be presented to the Board. AmSpa will continue to closely monitor these changes and will report any further developments.

Tags:  Med Spa Law  Med Spa Trends 

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

Posted By Administration, Monday, June 10, 2019

vlog doctor

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

(Click here to read part 1)

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

There is nothing illegal or even necessarily unethical about this but, on occasion, these videos make the surgeons and their staff members look unprofessional, especially depending on how they act during the procedure. While acting silly is almost expected from those engaging in social media today, it can be argued that medical professionals should hold themselves to a higher standard. If the purpose of the video truly is to educate rather than raise the surgeon’s profile, this sort of behavior should not be highlighted.

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

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

Crossing Ts, Dotting Is

Although this should probably go without saying, it is critically important that any surgeon or medical spa planning on conducting a social media campaign receives written consent from featured patients that thoroughly cover all HIPAA and local patient privacy laws. The forms used for this must be very specifically drafted in order to address the legal minutiae of social media, so anyone planning to do this needs to be very careful to ensure that the patient understands exactly what is going to happen. This is not the sort of form that anyone can simply download off the internet—it will need to be vetted by an experienced health care attorney to guarantee that no legal entanglements result.

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

Direct Messages

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

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

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

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

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

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

Posted By Administration, Friday, June 7, 2019

doctor vlogger

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

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

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

Social Studies

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

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

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

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

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

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

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

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