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Join AmSpa at the Asheville Medical Spa & Aesthetic Boot Camp EXTRA

Posted By Administration, Friday, May 24, 2019

asheville omni hotel

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

Starting next Saturday, June 1, AmSpa will host its Asheville Medical Spa & Aesthetic Boot Camp EXTRA at the Omni Grove Park Inn. We’re extremely excited for the opportunity to help medical aesthetic professionals develop their practices in this beautiful setting. There’s still time to register for the event—just click here to sign up. Here is a quick overview of the program:

Saturday, June 1

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

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 11 – 11:30 a.m.: The Marketing Plan, presented by Terri Ross (Terri Ross Consulting)—Renowned medical spa consultant Terri Ross shows you how to most effectively market your practice using market research and defining your objectives.
  • 11:30 a.m. – 12:30 p.m. The Social Media Plan, presented by Danielle Smith (Smith & Popov)—This session will help you determine how to promote your medical aesthetic practice using cutting-edge social media techniques.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Renee E. Coover (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4 – 5 p.m.: The Lessons, presented by Louis Frisina—Every medical spa is different, but the successful ones share several common traits. In this session, Business Strategy Consultant Louis Frisina discusses the qualities that are typically found in practices that bring in a significant amount of revenue.
  • 5 – 6 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.

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

Sunday, June 2

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

  • 8:30 – 9 a.m.: Anatomy of a $5-Million Med Spa, presented by Alex Thiersch (AmSpa)—Have you ever wondered what the difference is between your medical spa and one that’s mega-successful? It might be less significant than you think. This presentation will show what a $5-million med spa is doing right—and what you might be doing wrong.
  • 9 – 10 a.m.: The Financials, presented by Bryan Durocher (Durocher Enterprises)—At the end of the day, the money you’re bringing in is the most important measure of your practice’s success. This presentation will, among other things, demonstrate how to properly develop a budget and use metrics to determine your med spa’s strengths and weaknesses.
  • 10:30 – 11:30 a.m.: The Digital Marketing Ecosystem, presented by Audrey Neff (Crystal Clear Digital Marketing)—Find out how to effectively spread the word about your medical aesthetic practice and how best to determine what’s working and what’s not. Your practice’s digital presence is more important than ever before, and curating it should be a top priority.
  • 11:30 a.m. – 12:15 p.m.: Medical Aesthetic Hot Topics Panel, featuring Page Piland (Galderma), Audrey Neff (Crystal Clear Digital Marketing), Terri Ross (Terri Ross Consulting) and Nealy Skeldon (Environ Skincare)—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1 – 1:45 p.m.: The Consultation, presented by Terri Ross (Terri Ross Consulting)—As the old saying goes, you never get a second chance to make a first impression. Learn how to put your best foot forward with effective patient consultations—and how to turn them into consistent business.
  • 1:45 – 2:45 p.m.: The Long-term Revenue, presented by Bryan Durocher (Durocher Enterprises)—Simply being successful isn’t enough for a medical aesthetic practice; you have to know how to maintain and grow your success. In this session, Bryan will show you how to build patient loyalty and move your business forward.

Monday, June 3

The Boot Camp begins at 8:30 a.m. with a continental breakfast.

  • 9 a.m. – 12 p.m.: Making Money in Your Medical Spa, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and get a preview of The Roadmap to a 7-figure Medical Spa—Terri’s sales training course—which will show you how to convert web leads and develop phone skills, both of which are vital to medical spa success.

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

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

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

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Understanding the Legalities of Off-Label Use

Posted By Administration, Monday, May 20, 2019

drugs

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

The use of pharmaceuticals for treatments that are not specified by the U.S. Food and Drug Administration (FDA) is known as off-label use. This is a somewhat controversial practice, and many in the medical aesthetic industry may not fully understand why this is the case. However, if physicians use common sense and the medical information that is available, they can avoid legal entanglements. Here are a few things to keep in mind when considering off-label use in a medical spa setting.

Considering Use

In most cases, it is legal for a doctor to use FDA-approved medications in ways that are different from what the label specifically mentions. For example, Botox originally was specified by the FDA for use in the treatment of incontinence caused by spinal cord injuries or multiple sclerosis, migraines, upper limb spasticity, pain caused by cervical dystonia, axillary hyperhidrosis (sweating), blepharospasm (eye spasms) in children with dystonia, and strabismus (crossed eyes) in children. The reduction of facial wrinkles is not on that list, but it became by far the most prevalent use of the drug, and over the past 15 years, Botox has received three indications for cosmetic use. It is typically up a doctor’s own medical judgment to determine if a medication can be used for other treatments.

Also, it’s worth keeping in mind that the FDA does not govern the practice of medicine; it governs drugs. State medical boards govern the practice of medicine. Therefore, a board-certified doctor can determine how to use a particular drug.

“To be very, very clear, the FDA has no ability—zero ability—to have any control over how a physician practices,” said Bradford Adatto, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. “They are not in the business of regulating physicians. If you as a physician want to do something that’s off-label, it doesn’t affect you at all.”

In fact, off-label use has led to medical breakthroughs in the past. Aspirin, for example, was originally specified only to treat headaches—after it was introduced, doctors discovered that it thins the blood, and they began using it to treat heart congestion. (It has since been specified by the FDA for use in heart patients.) In the medical aesthetic industry, doctors have been known to try to use fillers and Botox in innovative ways to try to solve unusual problems presented to them by patients.

Regulatory Issues

Should patients and medical spa staff members worry about their doctor conducting off-label treatment? Generally, the answer is no, as it is up to the doctor’s judgment, and one can reasonably assume that judgment is informed by thoughtful research and years of experience.

“The physician has the ability to treat the patients based on their own medical knowledge, what other peers are doing, what is documented in medical journals that are out there or experiments they’ve done,” Adatto said.

However, doctors also have been known to use drugs on patients for more experimental purposes, and when that happens, state medical boards can intervene.

“If I, as a physician, am doing something that no one else is doing, and my medical board wouldn’t approve of it—there’s no medical journals on it, and I’m way off the skis of where everybody else is going, and I am just sailing in a direction where I’m all by myself—I could then be in trouble with my medical board for experimental use that’s outside the community of care of that particular specialty,” Adatto said. “You don’t want to be going in a situation where a medical board does not approve of that or believes it is too experimental or is not within the typical standard of care for a patient.”

If a physician is found to be using pharmaceuticals irresponsibly, he or she could be censured by the medical board and lose his or her medical license. In addition, he or she will need to explain his or her actions to the board.

Reckless Endangerment

In addition to facing sanctions from his or her state’s medical board, a physician who engages in reckless off-label drug use may be subject to legal liability issues. If a physician is found to have harmed a patient with his or her off-label pharmaceutical treatments, he or she could be sued for malpractice. If the off-label use resulted in serious injury death, a doctor can even be subject to criminal prosecution.

You may remember the case of Dr. Conrad Murray, the personal physician for music legend Michael Jackson. Murray was found complicit in the Jackson’s death because he improperly administered propofol—a drug specified for use as an anesthetic—in order to help the “King of Pop” sleep. He was found guilty of involuntary manslaughter and sentenced to four years in prison.

“Those drugs are usually only used for surgery, but there are other physicians who have used it to help calm individuals,” Adatto said. “It just then goes back to, not that many doctors were using it—it was a very small community that was using it—hence the malpractice, and then the liability of jeopardizing your license for being so far off-label.”

A doctor who is administering pharmaceuticals off-label also must be completely forthcoming with the patients being treated and obtain their express consent prior to providing these treatments. Misleading patients as to the specified use of the drugs being administered is another excellent way for a doctor to attract the attention of a state medical board.

“If you’re saying that this drug has been approved for this, and the medical board considers that what you’re providing is false or misleading information, that’s another potential issue,” Adatto said. “When you’re treating a patient on the front end, you must get that consent in order and make sure that the patient understands that the drug has not been approved for this type of use.”

In order to prove he or she has properly acquired consent for these treatments, the physician should be sure to get it in writing.

“We would always recommend to physicians that if you are going to be using a drug often for off-label, make sure you have a written consent that then describes that, so that a patient can also sign off on it, knowing that they received it both orally and in writing,” Adatto said. “That’s going to protect the physician, showing that they did tell this particular patient that they were using this drug for an off-label use, and the patient understood that and assumed some of those risks.”

Sensible Solutions

Off-label use can be a particularly tricky issue in medical spas, since non-doctors are sometimes the ones administering these treatments. Everyone in a medical aesthetic practice must understand that off-label use is a medical decision that is to be made only by a doctor. For example, a nurse administering an off-label pharmaceutical must be following a doctor’s order, and the decision needs to be established following proper delegation protocols.

If a doctor uses good judgment backed by research and is forthcoming with patients about why he or she wants to administer that drug in a manner that is not directly approved by the FDA, off-label use should result in no legal issues. However, obtaining patient consent is vitally important in cases such as these, so doctors should consult with their healthcare attorneys to verify that the consent they obtain will shield them from potential action.

In many cases, doctors who provide off-label treatments are simply attempting to help their patients. Providing them the leeway to do so has led to important medical breakthroughs and changed countless lives for the better. As long as doctors take the proper precautions, off-label use is perfectly acceptable from a legal standpoint.

Tags:  Med Spa Law  Med Spa Trends 

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Differentiating Your Practice: Choosing the Right Aesthetic Treatments to Set Your Practice Apart and Meet Client Needs

Posted By Administration, Thursday, May 16, 2019

cynosure

More than ever before, consumers are seeking out aesthetic treatments to help them feel and look their best—even if it means paying out of pocket. This means profit and growth opportunities for medical spas and medical aesthetic practices, but also comes with the pressure of keeping up with high demand, evolving industry trends and the latest technology.

With hundreds of treatment options available to address a myriad of patient concerns, it can be a challenge to determine what investments will bring the greatest returns to a practice and enhance its competitive edge.

This process of selecting and investing in new technology involves careful evaluation across many factors, including the practice’s current and prospective client base, the versatility of the technology on the table, and the technology provider’s capabilities to serve as a true partner to the practice.

Evaluating Current and Prospective Clients

It’s no secret that the demographics of those seeking out medical aesthetic treatments have changed and continue to evolve. Gone are the days when older women looking to slow the effects of aging were the only target market for medical spas and medical aesthetic practices.

Instead, today’s Millennials and men represent strong and growing populations of those receiving aesthetic treatments. Yet, each group approaches aesthetic treatments differently and are looking to address diverse present—and even future—concerns. This means medical spas and aesthetic practices could miss out on key growth potential if they do not look beyond the needs of their traditional client base to target new customers, with proven technology designed to address those specific concerns.

Radiofrequency (RF). Millennials are becoming increasingly interested in non-invasive skin treatments and are turning to radiofrequency (RF) technology in numbers never-before-seen. Although there are many RF devices on the market, those that offer differentiators in the realm of anti-aging and preventive maintenance are in highest demand. Dr. Dianne Quibell of MD TLC in Wellesley, MA, says, “My Millennial patients are requesting treatments using RF technology, including Cynosure’s TempSure Envi treatment, to tighten skin through soft tissue coagulation, minimizing facial fine lines and wrinkles, and temporarily improving the appearance of cellulite. Millennial patients love that they can incorporate these treatments into their beauty routines without downtime to address current concerns and future signs of aging.”

In addition to addressing active skin problems, RF technology is becoming increasingly popular for preventive skin maintenance, with Millennials thwarting the signs of aging before they even appear. With an increase in active—instead of reactive—beauty maintenance, practices could expect to see RF technology increase in popularity, particularly with this age group.

Non-invasive body contouring. Although women have historically been more accepting of—and forthcoming with—their cosmetic procedures, more men than ever are receiving cosmetic procedures. In particular, advancements in non-invasive body contouring procedures have helped men become more comfortable with receiving treatments, because they can now return to work immediately following the procedure with no downtime required.

Dr. Quibell continues, “Although many of the men I treat lead healthy, active lifestyles, most people have stubborn pockets of fat that seem impossible to lose, even with diet and exercise. The ability to undergo a 25-minute procedure, like SculpSure treatments in my office, that reduces up to 24% of treated fat cells without surgery, has captured the attention of men nationwide.”

As the audience for medical aesthetic treatments grows and diversifies, practices must target new prospective clients by identifying the technology best suited to address their concerns. Millennials and men continue to invest in treatments, meaning that both RF technology and non-invasive body contouring procedures are here to stay, because they provide real results with no surgery or downtime required.

Selecting Versatile Technology Options

When selecting new technology, practices can maximize their return and make major impact on their treatment offering by investing in technology with versatile functionality.

New technology innovations can perform multiple treatments or applications with one piece of equipment. This means that practices can benefit from multiple revenue streams from just one investment.

For example, the Icon platform is a flexible and versatile system that leverages IPL  and laser technologies. Through one piece of technology, Icon addresses several client concerns, ranging from hair removal to procedures for pigmentation, vessels, wrinkles, scars, and stretch marks, while offering a cost-effective, impactful way for practices to expand their offerings.

With other dynamic, multi-application systems hitting the market, practices can maximize their spend while also enhancing their portfolio of treatment options—all with a single investment.

Choosing a Partner, Not Just a Provider

Selecting new technology for your practice is an important decision that impacts your business’s bottom line and growth potential, as well as client satisfaction. It’s important that the company you purchase from will serve as a partner with your business, and not just a provider.

Providers become partners when they value a customer’s practice as an extension of their own business and offer turnkey solutions and dedicated support to ensure success. The value of a company’s overall commitment to improvement through innovation and client service, as well as their longevity in the space, are key factors when comparing their promises and evaluating their impact on a practice.

Practices should carefully select manufacturers based not only on the equipment they sell, but on the on-going support they provide by asking key questions, including: “Will this company support my facility through service and technology upgrades that will help serve our needs and the needs of our clients?”

With constant advancements in treatment technologies, it can sometimes be difficult to hone in on the options that will offer the most to both the practice and its clients, while also differentiating the practice in a competitive market. When investing in new aesthetic technology, balancing the needs of clients with the goals of the practice will ultimately result in sustainable success and satisfaction.

Cynosure, A Hologic Company (Westford, Mass.) is a global leader in advancing and innovating medical devices for aesthetic procedures and precise surgical applications. Its non-invasive and minimally invasive technologies enable plastic surgeons, dermatologists and other medical professionals to address skin revitalization, body contouring, fat removal, cellulite, scarring, tattoo removal, gynecologic health, unwanted hair, excessive sweating, and vascular and pigmented lesions. Cynosure also markets radiofrequency technologies for facial plastic and general surgery, gynecology; ear, nose and throat procedures; ophthalmology; oral and maxillofacial surgery; podiatry; and proctology. Established in 1991, Cynosure sells its products globally under the Cynosure, Palomar, ConBio and Ellman brand names.

Tags:  Guest Post  Med Spa Trends 

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How Core Doctors Can Cash In on Medical Spas

Posted By Administration, Wednesday, May 15, 2019

core doctors

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

The medical aesthetic industry continues to boom, and core doctors—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and cosmetic dermatologists—would seem to be set to profit in this space. As physicians, they are allowed to own medical spas, and they can ideally not only profit from the medical spas themselves, but also use them to direct business to their surgical practices. After all, medical spas tend to offer non-invasive procedures that are similar to some things core doctors do, and it does stand to reason that if patients go to a medical spa looking for a Botox injection, they might eventually want a nose job or a face-lift. That being the case, the core doctor who owns the medical spa should be uniquely positioned to offer his or her services.

However, that’s not necessarily the case. I chat with core doctors all the time, and those who open medical spas intending to use them primarily as feeders for their practices tend to view them as poor investments. Their medical spas tend to fail, and the amount of business they drive to their surgical practices is insignificant.

In truth, medical spas that are designed primarily to act as feeders for surgical practices are set up to fail, and most core doctors tend to be very bad medical spa owners. They typically don’t understand the medical spa business, how much work it takes, the profit margins, the necessary volume, and numerous other factors vital to maintaining a successful medical spa. But that doesn’t mean that a medical spa can’t still be a successful business for a core doctor or help to generate surgical business—it simply means that a core doctor needs to understand the realities of the medical spa industry before he or she decides to dive headlong into it.

A Singular Paradigm

The business model core doctors typically understand is very different from the one under which medical spas operate. Surgical practices offer big-ticket procedures, such as breast augmentations and face-lifts; they do not need to deal with a large volume of patients, and they do not need to market themselves like a retail outlet—by the nature of their business, they tend to generate sufficient revenue to get by.

While medical spas must follow the same rules and regulations to which more traditional medical facilities adhere, they are unique in that their services are entirely elective and entirely cash-based. People who use medical spas do so because they want to, and treatments at medical spas are much less expensive than those available from core doctors’ surgical practices. Therefore, for a medical spa to succeed, it must have a lot of patients, its employees must master the art of selling, and it must entice patients to return. In other words, it must operate like a retail center rather than a medical office.

For this reason, medical spas need to be run with a totally different mind-set than core doctors are typically used to. Medical spas owned by core doctors who do not adapt to a more retail-oriented emphasis often end up failing. When I tell core doctors that I have medical spa clients who generate up to $6 million annually, many of them cannot wrap their minds around how that is possible.

A New Perspective

In order for a medical spa to create business for a surgical practice, it must first succeed on its own terms. To facilitate that, core doctors typically need to let others run their medical spas. Core doctors need to understand that the medical spa business is much, much different than the ones they are used to, and they need to partner with people who are experienced with marketing and sales in a retail environment.

A core doctor’s time is better spent performing highly profitable surgical procedures, which medical spas cannot do. If a core doctor can get an experienced businessperson to operate the med spa, they will have a much better chance to succeed. Giving up this control can be difficult for core doctors, since a lifetime of academic and financial success tends to make them think they can achieve anything. However, most doctors don’t go to business school—they don’t know retail and they don’t understand sales. These qualities—rather than medical knowledge or surgical skill—tend to lead to medical spa success.

In addition, medical spa team members must be provided the tools and processes to sell. A medical spa receptionist, for example, should not be someone being paid $12 an hour with no experience; he or she should be one of the highest-paid people on an administrative staff, because he or she needs to be able to sell.

A medical spa also should provide talk tracks for nurses and aestheticians so they understand that their jobs are about selling themselves and the doctor. Employees at medical spas also need to understand that selling retail products is extremely important to maintaining a healthy business. These characteristics of successful medical spas may seem distasteful to doctors, who are used to professional environments that are less aggressive, but this is the reality of the medical spa industry, and every day more and more physicians discover this to be true.

The businesspeople who enter the medical spa industry are willing to do whatever it takes to be successful. A core doctor might believe he or she doesn’t need the help, but chances are the opposite is true.

There are several resources in the AmSpa store to help you build your business and train your team to put your medical spa practice in an excellent position to succeed.

The Practice of Medicine

A medical aesthetic practice must be focused on sales, but it also is required to follow the medical rules and regulations of the state in which it is located. These laws can vary significantly depending on the state, so a med spa operator should consult an attorney familiar with the industry when setting up the practice and procedures. AmSpa members can check their state’s medical aesthetic legal summary to learn about the rules and regulations governing their practice.

Most states observe a doctrine known as the corporate practice of medicine, which decrees that a medical practice must be owned by a physician or a physician-owned corporation. As previously established, medical spas are retail outlets, but they also are unquestionably medical practices, so medical spas must be entirely owned by a doctor or his or her corporation in states where the corporate practice of medicine is observed.

This can present problems for a core doctor who wishes to partner with a businessperson to run a medical spa, because the businessperson likely is going to want some equity in the practice. However, giving any ownership stake to a non-physician is illegal if the state where the medical spa is located observes the corporate practice of medicine.

Opportunities for Ownership

There are solutions, however. If a core doctor wishes to partner with an entrepreneur to open a medical spa in a corporate-practice-of-medicine state, he or she can set up a management services organization (MSO). An MSO provides practice management services, while the doctor, for whom a separate company is created, exclusively provides medical services.

This arrangement, known as a management service agreement (MSA), allows the non-physician who owns and/or operates the MSO to supervise almost every aspect of a medical aesthetic business, including branding, marketing, owning the real estate, payroll, human resources, accounting and billing—everything except the administration of medical services.

This is akin to a lessor/lessee situation. Generally, the MSO owns and maintains the facility, while the doctor inhabits the space. The doctor pays the MSO for the right to occupy the space, and the MSO acts as a landlord, maintaining the facility and keeping the doctor as comfortable as possible.

However, unlike a rental agreement that is managed by a lease that dictates the occupant pay a set amount of money for a certain term, the amount paid to the MSO fluctuates according to the amount of money the physician is paid by patients. If the medical organization treats more patients in a term than it did the previous term, the MSO will also make more money. This represents a sort of equity—in function, if not form. Read more about MSOs here.

The corporate practice of medicine also dictates the ways medical spa employees can be incentivized. In retail, salespeople are often offered commission—a percentage of the sales they make that meet certain conditions set by their employers. However, under the corporate practice of medicine, all payments for medical services must be made in full to a physician or physician-owned corporation. In these states, if a medical spa owner pays employees commission, he or she is engaging in fee-splitting, which is illegal.

This is somewhat common at medical spas. The people who own and operate these establishments generally only wish to reward the people who bring business to the practice, but if a medical spa is found to have engaged in fee-splitting in a state where it is illegal, the doctor who owns the practice could face the suspension or revocation of his or her license, as well as a significant fine. Additionally, the provider who receives the commission payment is subject to a fine. A performance-based bonus structure should be offered instead of commission. Read more about med spa compensation here.

Medical spa owners and operators who need to learn about the ownership requirements in their states should contact an experienced health care attorney to find out what is legal in their state.

Becoming a medical director for an existing medical spa, rather than opening a new practice, is another option for a core doctor. Several core doctors I have represented are doing this very successfully. They don’t need to deal with actual day-to-day operation of a retail store—they can simply lend their name to a medical spa, perform some consultations, oversee the practice’s other medical professionals, and then head back to their own practice rather than worrying about the intricacies of the business. This offers a core doctor a look at the industry without requiring him or her to make an enormous ownership commitment. It’s important, however, to understand the risks and responsibilities of med spa medical directors before committing to this course of action.

A Path to Success

The core doctors who oversee a compliant, well-run medical spa stand to gain a great deal from the arrangement. A successful medical aesthetic practice can earn a lot of money by itself, and if a med spa has a lot of patients, it makes sense that the number of referrals to an affiliated surgical practice will be higher than if it is struggling.

If a core doctor wants to enter the medical aesthetic industry, he or she cannot do it halfway. A medical spa that is created to function primarily as a compliment to a surgical practice is unlikely to find a great deal of success; one that is designed to succeed on its own terms, however, offers numerous benefits to its owners, including the possibility of increased surgical business.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn the legal and business best-practices you can employ to build and run a successful medical spa practice.

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

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How to Legally Offer Anti-Aging Treatments at Your Medical Spa

Posted By Administration, Tuesday, May 7, 2019

legalities medical

By Brad Adatto, JD, Partner, ByrdAdatto

“Alternative medicine,” “wellness treatments” and “anti-aging procedures” all have one element in common: Each has treatments and procedures that fall within the practice of medicine. Most states’ statutory definition of “the practice of medicine” includes any diagnosis, treatment or offer to treat a physical disease, disorder, deformity or injury by any system or method. Further, anytime the outermost layer of the epidermis is penetrated—whether by injection, abrasion or incision—the procedure is considered a medical treatment.

As such, treatments or therapy that include hormone replacement, stem cell and ozone administration are considered the practice of medicine. This limits who can actually perform these procedures and where these procedures can be performed. Over the years, we have had many individuals that choose to either ignore this advice or push back on this explanation, asking, “How is everyone else doing it?” As more individuals open “alternative medicine facilities,” “wellness clinics” and “anti-aging centers,” we have seen an increase in enforcement from state agencies, medical boards and law enforcement. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including anti-aging therapies. Here’s what you need to know.

  • The practice of medicine. Every state’s statutory definition of the practice of medicine includes diagnosis and treatment of a medical condition. Specifically, Texas’s definition of the practice of medicine includes diagnosing or treating any physical disease or disorder. Florida’s definition includes the diagnosis, treatment, operation or prescription for any human disease, pain, deformity or other physical or mental condition. As an example, diagnosing a person as an appropriate candidate for hormone therapy and giving orders for such treatment is the practice of medicine. Furthermore, facilities that offer ozone therapy as a medical treatment may be outside the scope of what is consistent with the standard of care for that state. At this time, the FDA has not approved of ozone therapy as a drug or device. Additionally, ozone therapy is not recognized nor approved as part of the practice of allopathic medicine by federal law or any state medical board. As such, providers offering this as a treatment must check with their state medical boards to confirm restrictions apply on “who” can provide complementary and alternative medicine.
  • Ownership. Essentially, the corporate practice of medicine doctrine prohibits non-physician-owned business entities from engaging in the practice of medicine. States adopting the doctrine are attempting to ensure a medical provider is responsible for the control and direction of a medical facility. You should develop your business and ownership model according to the laws of the state(s) in which you plan to practice. Because these laws vary from state to state, you need to know how to legally structure your business and the type of liability that may be associated with the structure you choose. For example, in New York, the state limits the ownership of businesses that provide medical treatments to licensed physicians; other non-physician health care providers are prohibited from ownership of the medical facility.
  • Staffing. Medical professional scopes of practice not only vary from state to state, but also vary depending on the training, experience and skill of a medical professional. Therefore, you need to know who can legally perform anti-aging treatments in your facility. For example, let’s assume you meet the state requirements to provide stem cell therapy, and you recommend the injection of mesenchymal stem cells into a patient’s skin to improve skin tone. This is the practice of medicine. Who has the authority to recommend the treatment—physician, NP or PA? Who can actually inject the patient—RN or MA? It is critical to understand the diagnoses, delegation and supervision regulations before performing these procedures.

Brad Adatto, JD, is a partner at ByrdAdatto, a business, healthcare, and aesthetic law firm that practices across the country. He has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions, and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral, and private securities laws.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Join AmSpa at the Chicago Medical Spa & Aesthetic Boot Camp

Posted By Administration, Friday, May 3, 2019

chicago boot camp

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

Starting tomorrow, AmSpa will host its Chicago Medical Spa & Aesthetic Boot Camp at the Chicago Marriott Southwest at Burr Ridge, and we’re extremely excited for the opportunity to help medical aesthetic professionals develop their practices. There's still time to register for the event—just click here to sign up. Here’s a quick overview of the program:

Saturday, May 4

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

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 11 a.m. – 12 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.
  • 1 – 1:30 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing) and Nealy Skeldon (Environ Skincare)—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Renee E. Coover (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4:15 – 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, May 5

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.
  • 10:45 – 11:15 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, the Robinsons 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 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.
  • 2 – 3 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.

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

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

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

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Unsafe Practices by New Mexico Aesthetician Lead to Second HIV Infection

Posted By Administration, Wednesday, May 1, 2019

needle

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa), and Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

According to the New Mexico Department of Health (NMDOH), vampire facials administered at VIP Spa in Albuquerque have caused the transmission of the HIV virus to at least two customers. The spa, which was operated by an aesthetician, was shut down in September 2018 after an inspection found that needles were being improperly handled and disposed of, creating the possibility of the transmission of bloodborne diseases. NMDOH is offering free blood testing services and counseling to the spa’s former clients.

Vampire facials involve the extraction of the patient’s blood, the centrifugal separation of plasma from the blood, and then the reinjection of the plasma into the face with microneedling equipment in order to stimulate collagen production. The procedure has gained popularity in recent years thanks to the influence of Kim Kardashian, who posted images of herself experiencing the treatment to her Instagram in 2013, but later stated that she regretted undergoing it and that it was extremely painful.

Obviously, this sort of procedure presents numerous avenues through which contamination can occur. In New Mexico, drawing blood and performing microneedling are both considered to be medical procedures and must be performed by an appropriately trained and skilled person under the supervision of a physician or nurse practitioner, including physician assistants either in collaboration with or under supervision of a physician, registered nurses, licensed practical nurses and trained medical assistants. Aestheticians, such as the person who operated VIP Spa, are not licensed to perform or provide oversight for these procedures.

The medical aesthetics industry is thriving, but this is exactly the sort of thing that could kill it. All over the country, unqualified people are doing things they shouldn't be doing, not following the rules or being safe, and potentially causing incredibly serious health issues and even deaths, such as in this recently publicized case of plastic surgery practices in South Florida that have caused the deaths of at least 13 people. Situations such as these are exposing the seamy underbelly of the industry, and while legislators struggle to catch up with the issues that are emerging, compliant providers may well get caught up in any kind of blowback that results from incidents such as these.

As we’ve discussed here before, we have to do better. AmSpa is currently working to develop a set of standards that will help the medical aesthetic industry govern itself and provide patients with reliably safe, satisfying treatment experiences. Stay tuned to this space to learn more about this effort and what you can do to participate.

Medical spa clients shouldn’t have to worry about contracting life-shortening illnesses or even dying as a result of their aesthetic treatments, but if stories such as these continue to emerge, that’s exactly what will happen. People may decide that they are more afraid of running into bad actors than they are desirous of looking and feeling their best, and if that happens, it’s the death knell of the industry. We have to prevent this at all costs, and we hope widespread adoption of these standards can help accomplish this.

Tags:  Compliance is Cool  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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The Legalities of Body Sculpting

Posted By Administration, Monday, April 29, 2019

cryolipolysis

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 aesthetics 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 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 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 and therefore is 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 aesthetics 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 aesthetics 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, we are not aware of any laws that specifically address cryolipolysis for body-sculpting purposes, and until there is—or until an influential medical board rules on the matter—the grey area will remain at least somewhat grey. We recommend 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. 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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Botched Microblading Highlights Regulatory Gap in Missouri

Posted By Administration, Tuesday, April 23, 2019

microblading

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

“Hideous” and “crazy” are not terms you ever want associated with your business, so this news article warning of the dangers of microblading performed by unskilled businesses in Missouri is particularly alarming. The poor woman in the article received terribly applied eyebrows that led her to hide her face and spend thousands of dollars to have them corrected. We have previously covered how botched procedures can have a wide impact on the regulation and oversight of industry, and this situation is no different. We’ve seen it in Texas, New York and Florida—bad publicity draws the attention of legislators.

Most states treat microblading as a branch of tattooing and require practitioners to hold either a tattooing license or a more specialized permanent cosmetic license. And generally, these procedures must be done in licensed tattoo parlors. Missouri is unusual in that its Office of Tattooing, Body Piercing & Branding does not consider microblading to fall within the statutory definition of tattooing. Missouri’s definition of tattooing mentions an “indelible mark” that is placed under the skin; because of the depth of typical microblading procedures, they are only considered “semi-permanent.” As a result, microblading in Missouri is largely unregulated. A person does not need to undergo any training or certification before offering the service to the public. And as in the case of the woman in the news article, this can lead to some terrible results that leave lasting damage and cost thousands to correct.

Missouri House of Representatives member Nate Tate has introduced legislation to close this gap. House Bill 71 (HB 71)—which you can read in full here—would simply amend the definition of tattooing to include permanent and semi-permanent pigment being placed for cosmetic purposes in addition to creating designs, as in traditional tattooing. It is unclear if HB 71 has the momentum to pass this year—after being introduced at the beginning of the legislative session, it was referred to the Committee on Registration and Professional Licensing last week. Regardless of whether or not HB 71 ends up passing, all practitioners will want to make sure they are trained and skilled in any procedures they offer.

Tags:  Med Spa Law  Med Spa Trends  Microblading 

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Understanding Informed Consent in Medical Aesthetics

Posted By Administration, Monday, April 22, 2019

informed consent

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

When patients at medical spas agree to undergo treatments, they are putting their wellbeing into the hands of the physicians who treat them. Because of this, the physicians have a duty to be as transparent and forthcoming about the treatments they provide as possible. They need to tell their patients everything the patients need to know about the procedures they recommend, and they need to make sure that the patients completely understand what is being discussed. This is known as informed consent, and it is extremely important for medical spa owners and operators to understand what is expected of them in order to remain compliant with any laws to which they are subject.

What It Is

Informed consent is a necessary step that a physician needs to take, but it is also a somewhat nebulous concept, from a legal standpoint.

“There’s nothing required to put something in writing, as far as a disclosure,” said Jay Reyero, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. “I think the whole point of informed consent is to demonstrate that the physician or the provider has given the patient all the material information they need to make an informed decision.”

This can often be accomplished verbally, though the patient will need a sign a form stating that the physician has given him or her the information needed to make a sensible decision. However, putting everything in writing is an extra step that, while not necessary, can save a practice some headaches in the future.

“Nothing prevents anyone from putting more information down on paper and being very clear, and I would say that that’s the best-case scenario, because it’s very hard to argue against the fact that someone did disclose something to you if it’s sitting there on a page that you initialed next to or you signed,” Reyero said.

Regardless of how the physician chooses to obtain informed consent, however, making sure the patient actually understands the ins and outs of the procedure is the primary objective.

“The whole point of informed consent is that there’s certain information that a patient needs to be able to make an informed decision as to whether to go through with the procedure or not,” Reyero said. “When we’re talking about informed consent, we’re not just talking about a consent document—it’s more about all the information surrounding what goes into that particular document that they’re signing.”

The physician should convey information about the nature of the procedure, the potential risks and outcomes, and what to expect in the days and weeks following the treatment.

Going Off Label

One might presume that informed consent takes on even greater importance when a physician utilizes pharmaceuticals or devices in ways that are not explicitly approved by the U.S. Food and Drug Administration (FDA), also known as off-label use. After all, it stands to reason that a patient would need to know that the drugs being used are not indicated for this particular treatment. However, Reyero says that this actually makes very little difference in the informed consent process.

“Generally speaking, there’s no requirement to disclose that something is being done off-label, primarily because that’s being decided in the professional medical judgment of the physician, and so there’s nothing that specifically requires a physician to say, ‘This is off-label use,’” he said.

However, a meticulous practice may want to include this information when providing informed consent to patients. This level of transparency will never hurt a practice from a legal standpoint, even though certain patients may be more skittish about such things than others.

“There’s nothing that would prohibit someone from taking an added step of saying, yes, we want to create more protection for ourselves, so we’re going to go ahead and disclose that this is off-label use,” Reyero said. “But when you think about what off-label use is, that in and of itself doesn’t necessarily convey anything that’s material to what a patient would want to know to decide whether they should go through with the procedure.”

After all, the fact that the FDA has not approved a particular drug or device for a particular treatment should not necessarily matter, since FDA approval should not be taken to mean that any sort of non-indicated use is dangerous. In fact, board-certified physicians engage in off-label use on a daily basis, and if they are doing it in a conscientious manner, it is perfectly legal for them to do so.

“Off-label use just means that the FDA hasn’t approved this particular drug or this particular device for the particular use that we’re going through,” Reyero said. “It doesn’t pass upon whether that’s safe or not, and so that’s why there’s no specific requirement or duty for a physician to disclose that.”

Trials and Tribulations

On the other hand, if a physician is conducting clinical research and wishes to use a patient as a participant, the informed consent process is vital and must be handled with the utmost care.

“The FDA actually has a fairly comprehensive set of requirements for informed consent with respect to clinical trials or research,” Reyero said. “It’s a much, much more comprehensive discussion. The FDA terms informed consent as being a process. It’s not just saying, ‘Will you participate in this research study?’ It’s talking about what that research study is, and what to expect, and what not to expect, and the things that they could experience, and allowing the person plenty of time to consider the information and to speak with someone. It is much, much, much more comprehensive than your standard medical procedures.”

These guidelines can be found on the FDA’s website. The U.S. Department of Health and Human Services’ Office of Human Research Protections also offers a set of tips about obtaining informed consent for doctors conducting clinical research; these can be found here.

“It’s so much more comprehensive than just your standard medical procedure with its informed consent,” Reyero said. “Typically, that is judged based on the disclosure of material information that a reasonable person would want to know, or disclosure of material information that a reasonable physician would think is important for a patient to know.”

Location Location Location

As is often the case with the regulations that govern medical spas, informed consent requirements vary from state to state.

“Every state is different,” Reyero said. “They’re all going to have different informed consent statutes or informed consent laws. If someone feels that a doctor didn’t disclose something or did something wrong, they’re either going to sue them under a non-disclosure-type concept where they didn’t properly give informed consent because the physician didn’t disclose enough information, and that’s where those reasonable standards come in.”

More often, though, patients invoke their states’ negligence statutes, as they typically feel that the physician’s medical judgment did not live up to the standard of care the patient expected. These vary from state to state, so if a medical spa suspects that its physician is not doing enough to obtain informed consent, it needs to review its state’s laws and its current procedures with an experienced healthcare attorney to determine what additional steps need to be taken.

Evolution

Today’s medical spa patients are more concerned than ever before about knowing precisely what is going on with their treatments, so practices and physicians should expect that informed consent regulations will probably evolve to become stricter in the future.

“People out there feel that there should be more information given to patients to make these decisions,” Reyero said. “With healthcare, everything is about patients understanding and everything being transparent, and so there may be something of a push for more disclosures than not.”

Reyero recommends that physicians reveal everything they can to a patient up front, because whether or not they are required to do so, it offers patients peace of mind and offers physicians security from a legal perspective.

“My rule of thumb is always disclose as much as possible, because it can only protect you,” he said. “In reality, when you think about going to a doctor’s office or going to a provider’s office, just because something is two pages as opposed to one doesn’t affect my judgment. ‘I’m going to leave because now you’re having me sign four pages instead of two,’ or ‘I can’t believe they [require you to] sign so many pages; I’m not going to recommend them to my friends’—those aren’t really criteria for people who are selecting healthcare providers. I always say that if you can put more in there and show that you’ve talked with them and disclosed things and given them time to ask questions, you’re only going to better protect yourself in any claim that they did not fully understand what was going on.”

Ultimately, it is a physician’s duty to make sure his or her patients know what they are consenting to. They should be as transparent as possible and be thorough in documenting the fact that they have had those conversations. It will put them in a much better position if there’s some sort of legal entanglement as a result of a bad outcome.

Tags:  Med Spa Law  Med Spa Trends 

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