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Who Can Perform Aquagold Fine Touch Procedures?

Posted By Administration, 20 hours ago

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

Aquagold Fine Touch is a channeling device offered for sale by Aquavit Pharmaceuticals that has become extremely popular in the medical aesthetics industry. It delivers micro-droplets of a variety of drugs—typically including Botox and other toxins, as well as fillers—into the skin. What’s more, its manufacturer claims the treatments it provides are pain-free.

Unlike a typical Botox treatment, in which the drug is directly injected and paralyzes the muscle, an Aquagold Fine Touch treatment is essentially microneedling. It delivers tiny amounts of the drug with which it is loaded over a wide area—much wider than a Botox treatment can manage. It is suitable for sensitive areas where Botox is impractical or impossible, such as the neck, and because the doses are much smaller than typical toxin treatments, it tends to result in skin that looks more natural and vibrant. Patients who wish to avoid the “frozen” look that Botox and other toxins often produce are embracing this technology.

As is typically the case when such a product emerges, we at AmSpa are getting a ton of questions about who can actually perform Aquagold Fine Touch procedures. The treatment appears to be very straightforward—a provider simply applies the device to the skin like a stamp. Its simplicity raises an obvious question: Can an esthetician or licensed vocational nurse (LVN) perform this procedure?

It’s good that we’re getting these questions because it shows that medical spa owners and operators care about remaining compliant, but because technology moves faster than the law, it’s sometimes difficult to determine what the answers are when new technology emerges. However, we can use what we know about similar treatments and technologies to determine the most prudent course of action until government agencies make their rulings.

Simply put, the Aquagold Fine Touch is essentially a microneedling device, so a lot of the issues we’ve addressed in recent years regarding microneedling are likely also going to apply to it. Every state that has looked into microneedling has found it to be a medical treatment, so a good-faith exam must be performed before the procedure, and if a doctor is not administering the treatment him- or herself, it must be properly delegated.

Unfortunately for practices that would like to use unlicensed practitioners to perform Aquagold Fine Touch procedures, this takes them out of the scopes of practice for estheticians and LVNs. In addition, the fact that Botox and fillers are being administered raises the question of whether or not this represents an injection and, therefore, if it can be administered only by a registered nurse or, in some cases, a nurse practitioner, physician assistant or physician.

The only conclusion we can draw with any sort of certainty is that Aquagold Fine Touch will be regulated in much the same way as microneedling, both in terms of medical board rulings and FDA approval, which has become a bit of a sticking point for microneedling products recently. Additionally, mixing different drugs together, as many doctors do with the Aquagold Fine Touch device, may represent a violation of pharmaceutical regulations, as many IV bars are finding out. Does a practice need to be registered as a pharmacy and have pharmaceutical oversight? Can nurses do it? Can LPNs? Who is qualified, capable and allowed to do this under the law?

Unfortunately, I don’t have all these answers at the moment, but I am going to find out, so stay tuned to AmSpa for more about Aquagold Fine Touch treatments. Thus far, it has been very safe and very well received, but the industry needs to have a firmer grasp on the regulatory issues surrounding it.

Tags:  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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EmSculpt Laws and Your Med Spa

Posted By Administration, Monday, December 10, 2018

By Michael S. Byrd, JD, Partner, ByrdAdatto

Unless you’ve been living under a rock, you may have noticed the increasing number of medical spas and aesthetic practices popping up in areas across the country. Similarly, the variety of non-invasive cosmetic procedures are continuing to attract ― and now contract ― bodies into its facilities.

Using high-intensity focused electromagnetic energy, or HIFU, Emsculpt is the newest non-invasive aesthetic procedure in the body contouring market.  It induces supramaximal muscle contractions to burn fat and strengthen abdomen and buttocks muscles in weeks instead of the months it would take to get the same or similar results in the gym, or with the alternative butt-lift.

Emsculpt, and similar non-invasive procedures, are commonly referred to as “cosmetic” procedures which may suggest that the procedures are different from other medical treatments; but as names can mean almost nothing, so do many states that broadly define what constitutes the practice of medicine and medical treatments. In other words, states couldn’t care less about the attractive name of your business ― if it operates like a medical facility, employs like a medical facility and treats physical conditions like a medical facility, then it’s a medical facility.

Emsculpt, as is the consistent case with Coolsculpting and SculpSure, will be considered the practice of medicine and constitute a medical treatment in most states.  Although the law and enforcement of the law lag behind advances in technology, the various states generally look to see what happens to the body with the treatment.  For example, Coolsculpting causes changes in the body to eliminate fat;  Microneedling stimulates collagen production.  Both of these treatments are routinely considered the practice of medicine.

If Emsculpt is indeed the practice of medicine, this can legally impact who can own a business that provides Emsculpt.  Virginia and California are two examples of states that broadly define the practice of medicine and that would characterize Emsculpt the practice of medicine; however, Virginia allows  anyone to own a business that practices medicine, while California’s ownership laws are more restrictive. These state specific nuances are just as important when determining who can and cannot perform the procedure.

Compliance is not stagnate; rather it is a moving target that changes as the laws, technology, and providers change.  For more information and state law guidance on Emsculpt or other aesthetic procedures, please contact ByrdAdatto. AmSpa members receive a complimentary 15-20 minute annual compliance consultation call.

Michael S. Byrd , JD, is a partner with the law firm of ByrdAdatto. With his background as both a litigator and transactional attorney, Michael brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2016) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016).

Tags:  ByrdAdatto  Med Spa Law 

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Houston PD Appears to be Bringing the Hammer Down as Fourth Arrest Made in Houston Med Spa “Crackdown”

Posted By Administration, Thursday, December 6, 2018

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

The first line of this story from the local ABC affiliate in Houston says it all: “A licensed cosmetologist is the latest person arrested in a police crackdown on illegal medspa procedures.” This time, a local cosmetologist’s mugshot is accompanied by the now-all-too-familiar scene of a med spa employee being led away in handcuffs and charged with the unlawful practice of medicine.

This is, by my count, the fourth such arrest in the last month in the Houston area resulting from two separate undercover investigations. In late November, a med spa owner was led away in handcuffs after providing PRP services to an undercover officer without proper physician supervision. This followed closely on the heels of the well-publicized arrest of popular injector Michele Bogle, who was arrested for illegally injecting Botox, followed shortly thereafter by the arrest of Bogle’s medical director, Dr. Paula Springer. (Note: I had a great talk with Texas lawyers Michael Byrd and Brad Adatto about this arrest, which is available on our podcast. This is a MUST LISTEN for all Texas med spa professionals.)

The latest arrest appears to be correlated to the original two, which all emanate from Savvy Chic MedSpa in Spring, Texas. Savvy Chic MedSpa cosmetologist Melissa Galvan allegedly prescribed a weight loss pill to a patient. The patient ended up in the hospital after experiencing chest pains which led to the arrest. According to the news report, Houston PD believes that Bogle, Springer, and Galvan all worked together to “unlawfully practice medicine.” According to investigators, the prescription pad used by Galvan belonged to Dr. Springer. You can read the full story here (also posted in the AmSpa news section).

The fact that we have had two undercover stings and four arrests in the last month at Houston med spas is startling. While we have been saying for years that enforcement is coming, I never believed we would see this type of concerted and targeted effort to take down illegal med spas. Seeing med spa owners, injectors, and medical directors led away in handcuffs has got to be a sobering feeling for area med spas, regardless of whether they are compliant or not.

There is a lot to learn from this and I promise there will be more to come. I will put together some takeaways for Texas med spas once I gather my thoughts and learn a little more. In the meantime, please check out AmSpa’s legal summary for the latest on the law.

Tags:  Compliance is Cool  Med Spa Law  Medical Spa Insider Podcast 

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Medical Spas Still Have a Long Way to Go When It Comes to Compliance

Posted By Administration, Wednesday, December 5, 2018

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

The recent arrest of licensed vocational nurse (LVN) Michelle Bogle has shaken the medical spa industry to its core. Bogle, an employee of Savvy Chic Medspa in Spring, Texas, is accused of practicing medicine without a license for administering Botox injections, something that many, many LVNs—and much less qualified individuals—have done and are doing. Bogle’s arrest and prospective prosecution have far-reaching consequences for those in the medical aesthetic industry, but this sort of enforcement, while somewhat surprising, was inevitable, so it’s up to medical spas everywhere to maintain compliance with their states’ rules and regulations.

I could go to practically any medical spa in the country and find something that it’s doing incorrectly, from a minor OSHA violation to a HIPAA breach to the improper practice of medicine in the form of improper delegation or supervision. In AmSpa’s 2017 Medical Spa State of the Industry Study, it found that 37% of medical spas that responded to the survey admitted that they did not do any sort of in-person good-faith exam prior to a medical treatment. (Frankly, I think the actual number is closer to 50%, but some respondents likely weren’t being entirely truthful.) The fact that Savvy Chic was conducting exams over FaceTime is one of the reasons why the investigation that netted Bogle was launched.

Any treatment that impacts living tissue—which encompasses most of the treatments offered at a medical spa—is a medical treatment and requires a full exam before it can be administered. If roughly half of the medical spas in operation aren’t doing this, we as an industry have a long way to go. And if you’re shocked by the charge against Bogle, you shouldn’t be—administering Botox is a medical procedure and she is not qualified to perform it, so therefore, she was practicing medicine without a license. Even though it happens constantly in medical spas all over the country, that doesn’t make it right and, in fact, indicates the immaturity of the industry.

It is high time for everyone in the medical aesthetic industry to start taking this a lot more seriously than they are. If this industry is going to survive and grow and thrive, it is crucial that this starts being controlled. At a minimum, we have to understand the practice of medicine, as well as the proper delegation and supervision of medical treatments.

Another finding of AmSpa’s 2017 Medical Spa State of the Industry Study was that only 7% of the respondents said they had been investigated by a government agency. My concern is that, because enforcement has traditionally been so lax, there is not much urgency for medical spas to fix their compliance issues. However, a rise in enforcement has taken place over the past couple years, and I suspect that if we were to ask the same question today, the number of medical spas admitting they have been investigated would be significantly higher.

Compliance is never a problem until it’s a problem, but we as an industry need to want to do better, and we need to do it regardless of the threat of enforcement. The medical aesthetic industry will not be taken seriously as long as its practitioners are seen making perp walks on the nightly news. Everyone at every medical spa must respect the need for compliance and do what they can to achieve it. The Wild West days of years past are over, and the industry must evolve to become everything it possibly can be.

Tags:  Med Spa Law 

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New Ohio Law Provides Affirmative Defense to HIPAA Liability in Data Breaches

Posted By Administration, Friday, November 30, 2018

By Robert J. Fisher, Attorney, ByrdAdatto

If you work in a medical spa, you are undoubtedly using the internet in more ways than one. In the age of electronic health records, online patient portals, and rapidly expanding telemedicine, there is an ever growing amount of personal and medical information available to be illegally accessed by wrongdoers with keyboards. As a result, federal and state governments and agencies have taken the “stick” approach by penalizing those who fail to protect their data, such as the $16 million payment Anthem made to the federal government in August for a breach that exposed the personal information of nearly 79 million people, and by recognizing a private cause of action for individuals to sue companies who violate HIPAA standards (see our previous article here).

In contrast, Ohio has recently taken the “carrot” approach by passing the Cybersecurity Safe Harbor Act (“Cyber Act”) that takes a new angle on the data breach issue by incentivizing companies to develop data security plans by offering legal protection rather than by fear of penalty. In the first law of its kind, the Cyber Act allows companies to use an affirmative defense against tort claims resulting from a data breach if an adequate cyber-protection program was in place at the time of the breach.

However, for a company to use the safe harbor, its cyber-protection protocol must meet the criteria set forth by the Cyber Act. Specifically, healthcare companies and practices must meet sector-specific laws and standards such as HIPAA and HITECH both in the written plan protocol, and its implementation. Additionally, the Cyber Act is not one size fits all as each security plan must be tailored in complexity and scope based on certain factors such as structure of the company, sensitivity of information, cost effectiveness of security improvements, and availability of tools.

While this law is specific to Ohio, it may be a sign of laws to come nationwide that would further encourage healthcare companies to protect themselves from suit by implementing strengthened data protection plans. Further, it indicates that HIPAA continues to be the standard on which healthcare companies need to base their compliance programs, regardless of whether HIPAA specifically applies to them. As such, we continue to recommend that all healthcare companies and medical practices protect themselves by preparing and enacting a HIPAA compliant data protection plan, or having their current plan audited for sufficiency.

For more information on best practices, laws and regulations, attend The 2019 Medical Spa Show in Las Vegas, NV.

Robert J. Fisher’s passion for healthcare traces back to his high school days of shadowing doctors. His passion evolved in college to study as a pre-med major. The last major evolution of Robert’s interest in health care was the transition to an interest in health care law. With this education, a business attorney for a father, and a renowned orthopedic surgeon for a father-in-law, Robert has the pedigree for success as a business and health care attorney at ByrdAdatto.

Tags:  ByrdAdatto  Med Spa Law 

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Keep The Holidays Happy with Legally Compliant Med Spa Events

Posted By Administration, Thursday, November 29, 2018
Updated: Thursday, November 29, 2018

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

Many medical spas and medical aesthetic facilities thank their loyal customers and VIPs with events or parties during the holiday season, where people can undergo treatments while enjoying refreshments with friends and employees. However, despite the frivolity, medical spa owners and operators need to take care to observe all the rules and regulations that they would in the normal course of business. In fact, in a party setting, this might prove to be something of a challenge.

Principle among these concerns is patient privacy. In a party setting, it might seem like no big deal for operators and attendees to take pictures and post them on social media; in fact, it’s the sort of behavior that a traditional retail outlet might encourage, since it shows customers having fun in an exciting setting. However, if photos of a party your medical spa is hosting are posted without a patient’s consent, it is a violation of HIPAA and likely other state regulations related to patient privacy, since you are tacitly admitting that these are your patients. Make sure that anyone appearing in photos you want to post from the party has consented to you using his or her likeness in this fashion; this typically can be accomplished with a disclaimer on the invite, although you should check with your healthcare attorney to make sure that this covers you completely.

Also, regardless of where the party takes place—it’s common for patients to host Botox parties, for example—you must observe the same procedures and protocols that you would in the course of your everyday business. In most states, the law requires that a physician must conduct a face-to-face consultation with each patient who seeks to undergo a medical procedure, and regardless of whether you’re administering these treatments at a party or during normal business hours, they are medical in nature and subject to the rules and regulations that govern medical procedures in your state. (AmSpa members can check the legal summary of medical aesthetic laws in their state.) So by the letter of the law, a physician or licensed practitioner (such as a nurse practitioner or physician assistant) must take a history, conduct a physical and administer an examination to each patient.

After a successful consultation, the patient’s treatment can commence, and while that treatment does not necessarily need to be conducted by a physician or licensed professional, you must make sure that proper supervision is provided. Provided the procedure falls within their scopes of practice, non-licensed professionals—such as laser technicians—may perform the actual treatments in lieu of a physician. However, a licensed professional must be available during the treatment, should the non-licensed professional require his or her assistance.

It is a good idea to make sure that a physician or another licensed professional is always on-site while medical procedures are being performed. Most medical spa treatments have very little risk of complications or negative outcomes, but if one should occur at one of these parties, the presence of a licensed professional will help protect the business against charges of impropriety.

This might seem like a lot of trouble to go to for a party, but the last thing in the world you want is for your state board of health to leave a citation in your stocking. Make sure all your legal bases are covered, and have a happy holiday season!

Tags:  Med Spa Law 

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Can an Esthetician Do It?

Posted By Administration, Tuesday, November 20, 2018

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

The services that medical spas offer can range between traditional spa beauty treatments to cosmetic medical procedures. Just as medical practitioners have developed less invasive procedures to offer in their practices, so too have cosmetologists and estheticians adopted more invasive procedures. As discussed previously (and here), this can create issues when these procedures fall into the practice of medicine without a license or without proper delegation an oversight. 

The traditional scope of esthetician practice is usually limited to beautifying procedures and applications that do not invade the living tissue. Typically, living tissue ends up being defined as the stratum corneum, the very top most layer of skin. This is the case in South Dakota, where estheticians are limited to only “non-invasive” procedures that are confined to the non-living cells of the stratum corneum. Similarly, North Dakota forbids estheticians from performing any invasive procedures. This limitation to the stratum corneum allows estheticians to perform many of the services offered in traditional spas, but many of the services a medical spa offers will be outside of their scope of practice. (For individual states, AmSpa Members can refer to your state’s summary here.)

The North Dakota Cosmetology Board mentioned above offers a guidance document you can access here which specifically prohibits their practitioners from performing laser use, CoolSculpting, any sort of injecting, microneedling that invades the live tissue, and chemical peels over a certain strength. These cover many of the most popular procedures that medical spas offer. And since estheticians are the most commonly employed licensee in many medical spas, this can create a temptation to practice beyond their scope. In response to this, many states have passed rules and regulations that provide a legal way for estheticians to extend the scope of their services. This process has taken multiple forms which broadly fall into two categories: 1) expanding their scope or practice or 2) providing rules allowing estheticians to perform medical procedures under physician guidance. However these changes can bring their own risks.

In Minnesota, the legislature passed a law creating an “advanced practice esthetics” license that allows licensees to perform procedures that effect the epidermis. This seems like a minor change, as the epidermis is made of primarily of the stratum corneum. The other two layers of the epidermis are significantly thinner. However, it is enough of a change that many formerly prohibited dermatologic procedures would be permitted within this new scope of practice. In this case, the adopted rules for Minnesota’s advanced practice esthetic license allow practitioners to perform dermaplaning, microdermabrasion, and to use electrical- and light-based skin care treatments. These advanced practice licensees are still prohibited from using lasers, but the other procedures encompass a significant percentage of medical spa offerings. Oregon also has an advanced practice esthetician license that allows license holders to perform “advanced non-ablative esthetic procedures” including, among others, laser-based skin rejuvenation and cellulite reduction. After earning this license the advanced practice esthetician is able to perform services without physician oversight. However, they do need to maintain a collaborative agreement with a medical professional if patients need to be referred. Although both the Oregon and Minnesota advanced licenses prohibit injections, they would still be a versatile licensee to have as part of a medical spa’s team. 

Other states have recognized that, although estheticians may have skills that complement more invasive medical procedures, they still need guidance and oversight of a medical licensee. States such as Wisconsin provide detailed rules for estheticians performing services that are medical procedures under physician supervision. A person licensed by the Wisconsin Board of Cosmetology may provide laser hair removal, microdermabrasion, and certain chemical exfoliation procedures; however, this can only take place in a licensed salon and under the delegation, supervision, and written protocols from a licensed physician. Similarly, Kentucky forbids estheticians from performing common medical spa procedures, such as Botox injections, laser treatments and microblading unless under the direct supervision of a physician. Here, direct supervision means within immediate distance to be able to respond to the patient if needed. These states and others like them attempt to strike a balance between expanding esthetician and cosmetologist’s scope of services and providing sufficient medical oversight.

Many states do not have the formalized rules or roles that allow estheticians expand their scope or perform more invasive procedures offered Minnesota, Wisconsin, or Kentucky. In some of these states, physicians may still be able to delegate procedures to other unlicensed individuals known as medical assistants. This may include people who hold esthetician licenses, but usually requires that they not hold themselves out as practicing under their license. Texas is one such state: Estheticians and cosmetologists may only provide their services in a licensed salon. Furthermore, physicians are unable to delegate cosmetology procedures to those licensees. However Texas law and its medical board do allow physicians to delegate certain procedures to others, including medical assistants. Since these procedures are not within an esthetician’s scope of practice, they could only perform them as an unlicensed medical assistant under the supervision of a physician.

Estheticians can be very valuable and versatile employees to a medical spa. They offer a wide variety of services that complement and enhance the other cosmetic medical procedures offered by licensed health care professionals. And in the states that offer expanded scopes of practice or advanced practice licenses, estheticians can even perform some of the more invasive procedures offered. It is, however, critical that medical spas operate well within the rules for delegation and licensees’ scope of practice. Even where the laws and rules are seemingly clear in allowing a procedure to be done by an esthetician, caution should still be exercised. When a physician’s supervision is required, there is always a requirement that the physician confirm that, in their professional judgment, the person has the appropriate training, skills, and experience to perform the procedures. Clearly this is a subjective standard, and the physician’s judgement in regard to what constituted sufficient training and skill would come under close scrutiny by the medical board if there were ever a complaint or adverse patient outcome reported. The physician’s license would depend on the board agreeing with the physician’s prior assessment and, when a patient has been harmed, the board may be less inclined to agree. On the other end of the relationship, if the physician is not providing sufficient oversight or is allowing the esthetician too much free reign, the esthetician could be made vulnerable to discipline from their own board for exceeding their scope of practice or subject to charges of practicing medicine without a license.

It is critical to every medical spa’s success and to the continued success of our industry as a whole that medical procedures are performed by properly trained and licensed people under appropriate supervision well within the rules and regulations of each state. If you would like to learn more about the legal issues surrounding your medical spa you may want to consider attending The Medical Spa Show this coming February in Las Vegas, NV. 

Tags:  Med Spa Law  Med Spa Trends 

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Understanding CoolSculpting and Your Med Spa

Posted By Administration, Monday, November 19, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Whether you’re an entrepreneur or a veteran business owner of a med spa, you know that business tends to run hot and cold. But does it really matter that business is hot when lifestyle preferences are cooling down? Literally. CoolSculpting is the growing phenomenon that is shifting a culture that was once obsessed with burning fat to freezing it.

CoolSculpting offers a fat reduction alternative to liposuction and a lifestyle alternative to diet and exercise by freezing and eliminating targeted fat cells using a process called cryolipolysis. The process is noninvasive, nonsurgical, and FDA approved. But make no mistake, there are still plenty of legal considerations to navigate before entering into one of the fastest growing practices in the country.

While the procedure is commonly referred to as a “cosmetic” treatment, CoolSculpting, or cryolipolysis, is considered the practice of medicine and a medical treatment in many states. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including the ownership and staffing of a CoolSculpting business.

Here’s what you need to know:

Ownership. 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 CoolSculpting business and the type of liability that may be associated with the structure you choose.

You also need to know if there are any licensing restrictions on owning a business that renders medical services in the state(s). California, for example, limits the ownership of businesses that provide medical treatments to California-licensed physicians, but also allows partial ownership by a list of other non-physician health care providers, subject to strict and narrow business and ownership structure requirements.

The Practice of Medicine. What constitutes the practice of medicine or medical treatment varies from state to state, and these laws can be specific and nuanced to varying degrees. Therefore, you need to know whether CoolSculpting is considered the practice of medicine, and consequently a medical treatment, in your state. For example, Texas considers diagnosing a person as an appropriate candidate for a cosmetic medical procedure and giving orders for their treatment to be the practice of medicine.

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 the treatment in your facility. It critical that state laws governing who can legally perform medical treatments, such as cryolipolysis, are not confused since many states only permit state-licensed physicians, physician assistants, nurse practitioners, and certain other licensed healthcare professionals to perform cryolipolysis, subject to state laws governing delegation and supervision.

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:  Business and Financials  Med Spa Law  Med Spa Trends 

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What Does the Recent Texas Botox Arrest Mean to You?

Posted By Administration, Thursday, November 15, 2018

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

As many have seen in the news recently, a Texas LVN named Michelle Bogle from Savvy Chic Medical Spa was arrested under the claim that she was practicing medicine without a license.; specifically, she was offering Botox injections. Although all of the facts about the case are not known, AmSpa wanted to take this time to review the rules in relation to delegating cosmetic medical procedures in Texas. The state of Texas is fairly liberal in who it allows to physically perform Botox and other injectable procedures. Anyone with proper training may inject Botox and other cosmetic injectable as long as it is under the protocols, supervision, and delegation of a physician. The Texas Medical Board has adopted Rule §193.17 (available here) to provide guidance to physicians who delegate these nonsurgical cosmetic procedures. The rule applies to nonsurgical cosmetic procedures, including injecting or using a prescription medical device performed by someone who is not otherwise licensed to perform the procedure and not a physician, PA, or NP.  The rule includes 13 points that physicians must adhere to in properly supervising and delegating such a procedure to anyone other than a physician assistant or a nurse practitioner. These include the following.

  1. A physician is responsible for being properly and appropriately trained in the specific procedure, and keep records documenting their training.  
  2. Before the procedure is performed, the physician or a PA or NP acting under their delegation must perform an initial examination. This examination must include: taking a history, performing a physical exam, making a diagnosis, recommending treatment, developing a treatment plan, obtaining a patient’s informed consent, and providing emergency and follow-up care instructions. They must also maintain medical records, and have signed and dated written protocols and standing orders for the procedure
  3. Following the above examination and diagnosis, the procedure can be delegated to another person as long as a PA, NP, or physician is on-site, or the delegating physician is available for emergency consultation and able to conduct an emergency appointment if necessary.
  4. The physician, regardless of who they delegate to, maintains ultimate responsibility for patient safety. 
  5. The physician is also responsible for documenting and maintaining the patient records. 
  6. The facility must have a quality assurance program in place, including mechanisms to identify complications, adhere to protocols, monitor the quality of treatments, a review and improvement mechanism for protocols, and ongoing training.
  7. Physicians can delegate procedures only at a facility where they have either approved of that facility’s written protocols for the procedure or they have developed their own protocols.
  8. The physician must also make sure that the delegated person has appropriate training in several areas related to performing procedures (see the rule for details).
  9. The physician must have in place a written office protocol for the delegated person to follow in performing the procedure.  his protocol must identify the delegating physician, criteria for the physician, PA, or NP to screen the patients, and description of appropriate follow-up care including for complications, injury, and emergencies.
  10. The physician must make sure that the delegated person follows that written office protocol.
  11. Patients must sign consent forms before receiving any treatment. The form must identify potential side effects, complications, and identity of who will perform the procedure.
  12. The delegated person who performs the procedure must have a name tag which discloses their name and their credentials. 
  13. The facility must have at least one person on-site who is trained in basic life support whenever a procedure is performed.

Each of these above points are necessary to be in compliance with the rule. However, this article is not meant to be an exhaustive compliance check rather to give more of an overview. So, if you are a physician planning on delegating such procedures to anyone other than a PA or NP, please carefully review the rule in total or consult with an attorney to ensure that you develop policies and procedures that are compliant with its requirements.   

The implications of this story are far-reaching. This is the second instance of an LVN being charged with the unauthorized practice of medicine in recent months as a result of an undercover sting operation (the other occurred in California). AmSpa encourages all of its members—particularly those in Texas—to ensure that they strictly comply with every step of the Texas delegation and supervision rules governing cosmetic procedures. Following each step specifically is critical, and practitioners must take care to pay very close attention to the specifics of the rule and follow it exactly. As now has been seen, failure to do so may result in criminal prosecution, not to mention action by the medical and/or nursing boards.

Tags:  Med Spa Law 

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California Passes Amendement to New Law That Could Affect Your Med Spa

Posted By Administration, Friday, November 2, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Do you own or work for a med spa in California? If so, this is important news. Just two months after California passed their new sweeping consumer privacy law, the California Legislature has passed an amendment to the act that was submitted to the Governor on September 12th for signature. The original bill, the California Consumer Privacy Act of 2018 (“Privacy Act”), was signed into law on June the 28, 2018, creating the strongest protections in the nation on collecting and using consumer’s information (please see our previous article here for more details on the Privacy Act). As written, the Privacy Act would require substantial compliance efforts for businesses working with California residents. The amendment makes many changes and clarifications to the Privacy Act, and several will be beneficial to medical practices.

The most beneficial change for medical practices is the Privacy Act now does not apply to health care providers to whom the rules of HIPAA or California’s Confidentiality of Medical Information Act apply, so long as the practices maintain patient information in the same manner as they are required to maintain protected health and medical information. Protected health information and medical information covered under those laws were already exempted in the original law.

A second helpful change for medical practices is that the disclosure to consumers of their rights of deletion no longer needs to be on the website or in the privacy policies. Rather, it now only needs to be “reasonably accessible to consumers.” Previously, this would have necessitated medical practices making major updates to their websites to be compliant.

The amendment also narrows the broad definition of personal information covered by the law. Previously “personal information” included a laundry list of types of information, ranging from biometric data to employment information. Unfortunately, the laundry list still remains, but is limited only to data that is capable of being associated or linked with a particular consumer or household. This is helpful as it exempts aggregated demographic and trend data.

While the Amendment may have eased the burden of compliance for medical practices, it has not removed it. We are hopeful that most of the nuts and bolts compliance concerns will be fully addressed in the Attorney General’s forthcoming rule interpretation. Consistent with the amendment, the AG must release its rule interpretation by July 1, 2020. However, since the Privacy Act itself becomes effective January 1, 2019, medical practices will need to be mindful of how they are treating consumer information before the Privacy Act takes effect. Substantial processes and changes may still needed by medical practices to be compliant.

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:  Med Spa Law 

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