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Forest Park Verdicts Reshape Health Care Compliance in Texas

Posted By Administration, Tuesday, May 14, 2019

gavel

By Jay Reyero, JD, Partner, ByrdAdatto

After years of anticipation, seven guilty verdicts in the Forest Park Medical Center criminal trial—in addition to the 10 pre-trial guilty pleas—have reshaped the health care landscape in Texas, and the nation is watching. While the exact fallout from the stunning conclusion will take some time to play out (appeals will be filed), there are two immediate takeaways of how health care compliance has permanently been impacted.

The federal government’s use of the Travel Act, a federal law criminalizing business activities that are illegal on the state level, was one of the most closely watched elements of the Forest Park case. While originally geared towards organized crime, prosecutors in the Forest Park case used the Travel Act in the health care context to target a physician kickback scheme where federal programs were not involved. The most interesting but unresolved issue is exactly how successful, if at all, the Travel Act can be in health care enforcement efforts in Texas. Unlike the federal government’s success in New Jersey, the verdicts in Forest Park reveal the Travel Act was not expressly relied upon by the jury to convict the physicians involved.

Nevertheless, Forest Park demonstrates that the Travel Act is a very real and controversial enforcement tool the federal government believes can be successful and is willing to use to combat fraud and abuse. Based on this new federal strategy, health care arrangements in Texas must include a risk assessment of the application of the Travel Act. We would recommend this risk assessment even when no funds from federal programs are involved. The possibility of the federal government’s involvement naturally increases risk and the specter of scrutiny. Anyone involved in a health care arrangement should take immediate steps to reevaluate the arrangement, taking into account this heightened level of risk.

The importance placed on the intent of the parties involved is another aspect of the Forest Park case that was illuminating. At the center of the case were marketing agreements developed with the assistance of qualified health care counsel, which on their face appeared to be bona fide arrangements. More importantly, the agreements were developed and appeared to be structured in compliance with applicable kickback regulations. However, throughout trial, the federal government pressed that the parties intended to induce referrals, despite what the terms of the marketing agreement indicated. The Forest Park case reinforces a critical understanding in health care compliance that form must equal substance. Even when parties attempt to structure arrangements within the requirements of applicable rules and regulations, the underlying intent must be aligned, as any deviation can give rise to significant issues regardless of the form. As evidenced by the Forest Park case and the testimony supplied by many of those involved in the scheme who had already pled guilty, the greatest risk of exposing the truth behind the intent of the parties of any arrangement is those individuals involved in the arrangement. Therefore, anyone involved in a health care arrangement should examine the circumstances beyond the document and ensure the intent and actions of all involved are consistent with compliance expectations.

The Forest Park case is a signal that a bigger and brighter spotlight is now shining on the health care industry in Texas from a fraud and abuse perspective. Gone are the days when one could be comfortable with the historical inaction of the Texas government in kickback enforcement efforts, as now the federal government has a powerful new tool that allows it to step in to enforce state laws. Even if the Travel Act is not successful on the technical merits, the Forest Park case is a clear signal the federal government can still use it to get in the door to obtain criminal indictments and potentially lead to convictions. With the use—and possible success—of the Travel Act, all health care arrangements in Texas, regardless of which payors are involved, are facing a heightened level of scrutiny. Every provider in the state should be reevaluating their arrangements from a regulatory compliance risk perspective.

Jay Reyero, JD, is a partner at the business, healthcare, and aesthetic law firm of ByrdAdatto. He has a background as both a litigator and transactional attorney, bringing a unique and balanced perspective to the firm’s clients. His health care and regulatory expertise involves the counseling and advising of physicians, physician groups, other medical service providers and non-professionals. Specific areas of expertise include federal and state health care regulations and how they impact investments, transactions and various contractual arrangements, particularly in the areas of federal and state anti-referral, anti-kickback and HIPAA compliance.

Tags:  ByrdAdatto  Med Spa Law 

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Florida Office Surgery Reforms Pass House and Senate

Posted By Administration, Thursday, May 9, 2019

laws

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

A recent news article features shocking reports of patient injury and death at dishonest Florida plastic surgery clinics. These stories are heartbreaking to read. They include young children losing their mother, mothers losing their daughters, and people forced to live with pain and disfigurement because of complications from improperly performed procedures. The article calls out several clinics as being repeat offenders. To be sure, the vast majority of surgery clinics are run safely and ethically, but the clinics mentioned in the article are egregious examples of a malfunctioning oversight system.

Over the past two decades, Florida has become a mecca for plastic surgery, and many procedures there are performed in office settings outside of licensed hospitals or ambulatory surgery centers. To monitor and regulate these offices, Florida requires that all physicians register the offices where they perform complex procedures.

The current Florida office surgery registration rules divide procedures into three levels, based on their invasiveness and the type of anesthesia used. Level I procedures have a low risk of complication and require only local or topical anesthesia; these are procedures such as minor excisions of skin tissues or liposuction of less than 4,000 ccs of supernatant fat. Level II procedures use medication that can require conscious sedation and can include deeper tissue biopsies and hernia repair. Level III procedures require general anesthesia or greater sedation than Level II procedures.

Florida requires that all physicians register the offices where they perform Level II procedures that last longer than five minutes or any Level III procedure. Registered offices must undergo an annual scheduled inspection, meet certain standards, and report adverse incidents to the Department of Health within 15 days.

While current rules provide for some oversight of these offices, the enforcement mechanisms can be slow to implement and take effect, as evidenced by the linked article. In response to these gaps, lawmakers have introduced legislation that is designed to strengthen the process. The bills, known as House Bill 933 (HB 933) and Senate Bill 732 (SB 732), would expand the registration requirement to more offices and provide stiffer penalties and stronger enforcement for violations. In their current forms, both bills would require offices to register if they perform any Level II or III procedures, or if they perform liposuction of more than 1,000 ccs of supernatant fat, which is broader than the current rules. Additionally, the bills would allow the board to suspend or revoke an office’s registration or a licensee’s ability to operate, as well as impose penalties if they are discovered to not be in compliance with regulations. Legislators hope that this will give the board the tools to crack down on the types of unsafe operations described in the article and to prevent unsafe owners or physicians from switching offices to avoid detection.

Past efforts to increase regulation and enforcement for these types of clinics have failed to gain passage, typically getting stuck in committee. However, this year’s efforts appear to have been successful. SB 732 has received favorable votes from each committee and just last week passed the full vote of the Senate, from there it headed to the House. On May 1st, SB 732 unanimously passed the House vote. Now SB 732 heads to the governor’s desk for signature. Once signed, the provisions of SB 732 become effective January 1, 2020.

As is often the case with legislation like this, the burden and costs of compliance will fall most heavily on offices that already are safe and well run—they will need to update their policies and procedures and come into compliance with the new rules. If you believe your practice may be affected by these new rules or have questions about staying in compliance, contact AmSpa or ByrdAdatto.

Tags:  Med Spa Law 

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Botox Parties: What You Need to Know

Posted By Administration, Wednesday, May 8, 2019

botox

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

One thing I love about the med spa industry is that med spa owners and providers continue to innovate. The ideas that come from AmSpa members on marketing, branding and business are always impressive. This is one reason why it is difficult to keep track of what’s legal in the medical aesthetic industry—many of the ideas we are asked about are brand new. They’ve never been tested before, and therefore it’s difficult, to determine where the legal constraints are.

Botox parties are examples of this. These events are hosted by a med spa or a provider—either at the med spa or another location—and at them, people get together to socialize, learn about treatments and try new treatments. Often, the med spa provides discounts on product to get new patients in the door. These are highly social events, often featuring alcohol, that mix pleasure with aesthetics, which makes the idea of getting injected with a needle a bit more palatable.

I’m often asked whether these events are legal, particularly when they are held outside of the med spa—at someone’s house or a salon, for example. What’s more, are they worth it?

The answer to both of these questions is yes—they are absolutely legal in most states (Nevada recently passed a law restricting the injection of Botox and fillers to a doctor’s office, essentially banning offsite Botox parties), and they are absolutely worth it. But like most things in this industry, these answers are contingent upon you adhering strictly to the law. No amount of money is worth losing your license, and yes, nurses have lost their licenses because of improperly hosted Botox parties. AmSpa members can check their medical aesthetic legal summaries to find laws pertaining to Botox parties in their particular state.

Primarily, you need to remember that when you provide any offsite medical treatment, all the same rules apply. New patients must be examined by a doctor, nurse practitioner (NP) or physician assistant (PA) prior to being treated. Proper records must be kept. Consent forms must be signed. Before and after photos should be taken. Everything you are legally required to do at your med spa should be done at a Botox party.

Additionally, check with your insurance carrier before the party to ensure that you have coverage for offsite treatments, and double-check local ordinances regarding serving alcohol—you may need to obtain a permit for this.

Exam

A patient being treated by an RN without first seeing the doctor (or NP or PA) is the biggest legal risk at Botox parties, or any other social event involving med spa treatments. All patients must first be examined so that a plan can be set. This can only be performed by a doctor, or by an NP or PA operating under proper authority. Even if the patient consents to being treated by the RN without first seeing a doctor, the RN is not allowed to inject the patient without the exam.

At Botox parties, this can be difficult because new patients are socializing, alcohol is sometimes being consumed, and everyone is more relaxed. However, this is a step that must be followed, because an RN cannot practice medicine, so he or she cannot legally perform the initial assessment, establish the physician/patient relationship and set a treatment plan.

Consent

Obtaining patient consents—including privacy waivers, since treatments are usually performed out in the open—is also important. Providers also should be mindful of patients consuming alcohol. While obtaining consent from people who have been drinking is not strictly illegal, alcohol makes people less inhibited and often clouds judgment, which is not good when it comes to patient consent. All prospective patients should offer consent before they begin drinking, and you should try to keep the drinking to a minimum. This is not always easy, but trust me—if there’s an adverse outcome, you’ll wish that alcohol was not involved.

Privacy

You should also be mindful of photos and social media. These events are ideal for marketing purposes—people are having fun, everyone is happy, and you remove many of the clinical aspects of aesthetic medicine. However, you need to be careful when photos or videos are posted—every patient is entitled to privacy, and if any of them fail to sign a privacy release and an authorization to use their photos, you risk breaching their privacy.

Conclusion

So since these events are broadly legal, we need to ask—are these events are worth it? The answer is emphatically yes, provided you strictly adhere to legal guidelines. Botox parties and social events are great ways to introduce new clients to your practice, pre-book treatments and bring in some cash.

Offer discounts on treatments and pre-bookings—both for injectables and laser packages—is standard operating procedure, provided they are purchased that night. Patients are encouraged to bring friends and colleagues to meet the providers and learn more about aesthetics. It is not uncommon for a practice to earn six figures in treatments and bookings in just one day. Even that kind of money isn’t worth losing your license, however, so be vigilant with your compliance efforts.

I urge you to move cautiously when planning and hosting one of these events. Do your homework and ensure you are completely compliant. Go easy on the alcohol. Make sure you’ve got proper insurance. If you have any questions whatsoever, consult with a qualified lawyer ahead of time so that all the proper documentation is in place, the required personnel are available, and all rules are observed.

For more information on running your med spa legally and profitably, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps, and you could become the next med spa success story.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Compliance is Cool  Med Spa Law 

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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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Why Your Medical Spa Will Be Investigated

Posted By Administration, Monday, May 6, 2019

sad doctor

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

Medical spa owners and operators typically don’t think their businesses are going to be investigated by the regulatory agencies in their state, and historically, this is often the case. Agencies simply can’t keep an eye on every practice under their jurisdiction, after all. However, the recent growth of the medical esthetics industry has increased the amount of scrutiny it receives from these agencies, so the odds that your medical spa is going to be investigated are improving all the time.

If you practice is investigated, the consequences can be severe. Depending on what the agency finds, the practice’s physician’s license could be suspended, which could cause the practice to be unable to operate, and heavy fines may be levied. Severe infractions can even result in criminal prosecution. Understanding why these investigations are triggered will help you avoid them, so here are the top reasons why medical spas are investigated.

Intake Procedures

Most of the procedures performed at medical spas are considered to be medical in nature by regulatory authorities. Before these treatments are administered, a physician generally must conduct a face-to-face examination, wherein he or she determines the patient’s overall health and the extent of the patient’s issue. After this exam, the physician suggests a course of treatment. However, regulatory agencies have disciplined many medical esthetics practices because they do not properly administer these exams; in fact, this is the most common reason why these investigations are initiated.

Uncertainty over the status of minimally invasive treatments, such as Botox and filler injections, tends to lead to these violations. Many seasoned nurses have been cited for administering these treatments without an exam because they think an exam is not required, since for many of them, that’s the way it has always been.

In most states, the initial exam can be delegated to certain licensed practitioners, such as a nurse practitioner or a physician assistant, but the physician still must be involved with establishing this protocol and make sure it is always followed. Medical spa employees must understand that doctors are entirely in charge of medical treatments at their practices—only they can set the protocols, only they can set the treatment plan, and only they can prescribe and delegate others to perform that treatment plan.

Physician Oversight

Along the same lines, because medical spas are medical practices, a medical professional must always be on site. While a physician can delegate most of the practice’s medical treatments to others, including non-licensed individuals, a licensed professional—a physician, nurse practitioner, physician assistant or registered nurse—should be at the practice at all times to oversee these procedures. The type of treatment provided, as well as the type of practitioner performing the treatment, are important considerations, so if you’re not sure how your state defines certain treatments, check with your local health care attorney for more information.

Some procedures, such as microneedling and dermaplaning, traditionally have not been viewed as medical treatments, but now typically are. This complicates matters at medical esthetics practices where estheticians have been performing these procedures for years. Additionally, most states require a tattooing or permanent makeup license to administer microblading, which complicates matters further.

At some medical spas, physicians don’t pay much attention to what is going on and essentially serve as medical directors in name only. Some physicians oversee more than a dozen medical spas, which should tell you that they spend very little, if any time actually working at these practices. These practices probably do not have proper oversight, unless they have a large number of nurse practitioners or physician assistants on their payroll. Regulators can easily see if a physician appears to have too much going on and use that as a reason to investigate what’s happening at his or her medical spas.

Marketing

Regulatory agents tend to spend a lot of time searching the internet for potential violations, due to the lack of funding their agencies receive. If they search for terms such as “medical aesthetician,” for example, it’s not terribly difficult for them to find violations. Additionally, they typically can get an idea of the practice’s ownership structure and if it is in contravention of the agency’s regulations. If an agent finds that a practice’s website indicates that, say, an aesthetician or nurse owns the practice—in most states, only a physician or physician-owned corporation can own a medical practice—he or she likely will not hesitate to open an investigation of it.

Additionally, Medical spa owners and operators should not present testimonials that are hyperbolic or suggest that the practice offers services it cannot actually provide. Medical advertising regulations dictate that practices must only cite skills and accomplishments that can be proven. For example, if your practice advertises “the best Botox in Boston,” it is likely to draw attention from regulators, since that is not a fact that can be verified.

Regulators also search for indications that a practice has violated patient privacy laws, such as HIPAA, on social media. Anything that can identify someone as your patient—down to simply responding to a patient’s Facebook post—can be interpreted as a violation, provided you have not obtained the patient’s consent in advance. If you’re not sure if your social media activity is violating patient privacy laws, consult with an experienced health care attorney as soon as possible. (Author’s note: AmSpa works with national law firm ByrdAdatto, which focuses on medical aesthetic legalities, and as a member, you receive a discount off of your initial consultation, along with a number of other great benefits. To learn more about the benefits of an AmSpa membership, click here.)

Drugs & Equipment

Regulators are likely to initiate an investigation if a practice is found to have purchased pharmaceuticals that claim to be cleared by the FDA—but are not—from overseas sources. Only drugs and equipment that have been totally approved can be purchased legally in the United States; importantly, this means that in addition to the actual product, the FDA has approved all packaging and inserts.

There are two aspects of this issue. On one hand are potentially dangerous counterfeit drugs—typically Botox and fillers—that typically are manufactured in and purchased from China; these should be avoided at all costs. The prevalence of these products has declined in recent years as more owners and operators have learned about how dangerous they are, but they’re still out there.

On the other hand, “parallel importation” is a practice in which legitimate products sold in countries where price controls keep the cost of prescription pharmaceuticals low are resold to practices in the U.S. for far less than they would cost if purchased domestically. Parallel importation is broadly legal for most products, but it is understood to be illegal with pharmaceuticals, and the FDA has indicated a willingness to prosecute the practice. If your medical spa is found to be engaging in parallel importation, it very well might trigger an investigation.

Filing with the State Board of Cosmetology

Medical spas have to spend a lot of time and effort complying with regulations involving the administration of medical treatments, but they also must follow the rules related to purely aesthetic offerings. Most state boards of cosmetology require businesses that provide such services to apply for a cosmetology “establishment license”; this is called different things by different states, but essentially it is a registration with the board of cosmetology declaring that aesthetic services such as facials are being performed. Medical spas understandably tend to be much more concerned with maintaining medical compliance, so they often neglect to obtain this license.

Boards of cosmetology seem to be less formidable adversaries than medical boards, but they will cause significant problems for medical spas that ignore them. If your practice offers esthetic services, make sure it is in full compliance with the state board of cosmetology.

Straight & Narrow

Ninety-nine times out of 100, an investigation into a medical spa is triggered by a report to a regulatory body, and this is more likely to happen as a practice become more successful. Competitors might report a medical spa, sometimes for good reasons and sometimes out of professional jealousy.

Also, patients who are disappointed with the way they’ve been treated—whether they’ve actually been mistreated or not—may report a practice to a regulatory agency. A patient is unlikely to grumble if they he or she has a good experience, regardless of the outcome, but medical spas should always strive to provide patients with exceptional service so that they don’t do something irrational—after all, as all medical esthetics practitioners know, medical spa patients are, let’s say… a passionate bunch.

Finally, it’s not unusual for former employees to report medical spas to regulators if their departures were not amicable. Upon hiring new employees, a medical spa should set realistic expectations, provide proper job descriptions, and make sure they understand procedures, so that if they are terminated, it won’t be seen as a surprise or viewed as unfair in any way.

Tags:  Med Spa Law  Med Spa Ownership 

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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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