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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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Medical Spa Bad Press: Coming to Terms with Compliance

Posted By Administration, Thursday, November 1, 2018

By Alex Thiersch, CEO of the American Med Spa Association

Bad outcomes and patient injuries in medical spas are appearing in more and more headlines across the country. It is evident to many who work in the medical spa industry that there are a number of grey areas in the rules and regulations that govern it, and that certain unscrupulous medical spa owners and operators exploit these inconsistencies while sacrificing quality patient care to make money. Media pieces highlighting these bad actors in the industry are appearing with increasing regularity, and even the Doctor Oz show recently highlighted “Rogue Med Spas” that endanger patient safety. These reports express the industry’s problems to the public and, when the public catches wind of a health issue, you can bet that local, state and federal regulators will need to address it sooner or later.

View the full segment.

See AmSpa’s full statement on the segment here

The days of the medical spa industry being the “wild west” are likely coming to an end. So if your practice is not entirely compliant with your state’s medical statutes, it is certainly in your best interest to identify the ways in which it falls short and address them as soon as possible.

AmSpa members can check their state’s medical aesthetic legal summary to find the laws governing their practice.

The Truth

Stories such as the Doctor Oz report are not positive for the medical spa industry, but they’re not necessarily hatchet jobs, either—many medical spas are, in fact, operating illegally, and untrained, unqualified employees are burning patients with lasers, among other potentially serious violations.

Medical spas and laser centers have become so popular—and so profitable—that some owners and operators rush to open them and, as a result, they are often not properly formed and not compliant with state and local statutes. Traditionally, there has not been a great deal of enforcement of these violations, but this is changing.

Medical spas have become so prevalent that state regulatory agencies simply cannot ignore them anymore. As is seen in the rise of media coverage of these issues, patients who suffer unforeseen outcomes will not hesitate to complain to the media. Personal injury attorneys have also picked up on the trend—you may have noticed television commercials and print ads calling for clients to sue medical spas and laser centers. The story is out there, and it only takes one aggrieved patient to cause a medical spa’s world to come crashing down.

Although it is undeniable that there is a certain level of non-compliance that exists in the medical spa industry, medical spa owners and operators need to be asking themselves how they can start becoming an industry that regulates itself, so that they don’t have these types of continuing issues with state regulators.

Creating Compliance

To start on the road to compliance, medical spa owners and operators should take the following steps.

  1. Know the law. While there are grey areas, many answers can be found in state’s practice acts with just a little bit of searching.
  2. Reach out to local health care attorneys for evaluation. Most medical spas only contact a lawyer when they’re already in trouble, not at the front end where the lawyer can help prevent trouble down the road.
  3. Work toward understanding. You goal should be to understand the basic core principles regarding medical practice and realize that, while this is a lucrative industry that is often quite safe, there is still some level of danger.

AmSpa pledges to continue its efforts to educate medical spa owners and operators to make sure that they are operating in compliance with the law. It also aspires to educate the public in order for them to understand the difference between a medical spa that is compliant and one that is not, as well as inform them about what the treatments offered by medical spas actually entail. AmSpa is also pushing for standardization of laser training across the industry—in some states, there are no training requirements, and a lack of proper training can lead to outcomes such as the ones that Doctor Oz aired to the general public.

The industry needs to come together to discuss how it should be regulated, as it is clearly growing and is not going away. There is some guidance in the laws as they are written, but the states do not do a particularly good job in educating the public about what they say and mean. Still, enforcement is ramping up, and medical spa owners and operators must be properly prepared in order to comply and avoid more negative media coverage in the future.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn how to build and run your medical spa to be profitable and compliant with all of the laws in your state.

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

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Self-Regulation: Equipment Manufacturers and Training Centers Need to Get on Board

Posted By Administration, Tuesday, October 30, 2018

By Alex Thiersch, CEO of the American Med Spa Association

In this space a couple of weeks ago, I wrote about the need for self-regulation in the medical aesthetic industry. In that piece, I mostly focused on how medical spa owners and operators can help the industry by observing certain standards that AmSpa is helping to develop. However, the need for self-regulation is not limited to practitioners—it extends to equipment and device manufacturers, as well as clinical training facilities.

After an AmSpa Boot Camp or a consultation where I detail the legalities of laser use, for example, I’m often approached by attendees who say, “I was trained by a laser manufacturer, and they didn’t tell me any of this stuff.” What I’ve found is that there are a lot of people out there who give a lot of disparate information and, oftentimes, it’s not accurate and it leads people to believe that they can do things that legally they cannot do.

We at AmSpa have been working very hard since the organization’s inception to educate not only medical spa owners and practitioners, but also the industry as a whole. If everyone knows the laws under which they operate, everyone can be on the same page.

AmSpa works with many laser manufacturers that have listened to us and acted in very responsible ways. However, I’ve also heard countless stories from people who were told by manufacturers or training facilities that they can do something that they plainly cannot, and they feel like that is unfair.

This is not just an AmSpa problem or a medical aesthetic practitioner problem—it is an industry problem. The entire industry need to be on the same page. Every member of the industry needs to buy into the same set of standards, and we all need to be teaching the people who work in the industry the same thing. It makes no sense and does nobody any good to, say, take a long laser course and learn to perform treatments if a practitioner cannot legally administer them.

Therefore, AmSpa is calling on the entire industry—not just medical spa owners and practitioners, but also device manufacturers, drug manufacturers, and training facilities—to start taking compliance seriously, because it’s the only way for the industry to evolve in a positive direction. Everyone wants to succeed and make money, but if the industry is overly regulated due to negative outcomes and people acting in bad faith, it will be extremely difficult for the industry to become better and larger than it already is.

I’m looking forward to discussing self-regulation with everyone at forthcoming AmSpa Boot Camps. We will be in Orlando next week for our final Boot Camp of 2018, and our just-announced 2019 itinerary includes stops in Los Angeles, Chicago, Atlanta, Seattle, Dallas, New York and Orlando. Click here for more information and to sign up for a Boot Camp near you. We’ll also be discussing this matter at the Medical Spa Show in Las Vegas in February 2019. Click here to learn more about this year’s agenda and event … it shouldn’t be missed!

 

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

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Corporate Practice of Medicine: Living or Dead?

Posted By Administration, Monday, October 29, 2018

By Patrick Armstrong O’Brien, Legal Coordinator, AmSpa

Many states prohibit non-physicians from owning medical practices either directly or through a business entity. This is known as the Corporate Practice of Medicine doctrine, which AmSpa has previously discussed here. The concern these states have with corporate practice of medicine is that the non-physician control will interfere with the physician’s professional judgement in the physician-patient relationship. Whether or not that fear is founded, it has resulted historically in many states forbidding the practice. AmSpa members: To see what your state’s policy is please your state legal summary.

Over time, the practice of medicine has evolved and become more complex and interconnected.  Physicians no longer practice with just a bag and a stethoscope. They render medical services through a team of professionals and specialists who utilize an array of advanced machines. This complexity and interconnectedness has weakened much of the original motivation for the prohibition against medical services being delivered in a corporate structure. Often, these prohibitions are seen more as a hindrance than an aid to effective care. There has been a general trend to move away from or weaken this prohibition. This has taken the form of passing statutes that affirmatively allow corporate practice or remove the restrictions.  

On one end of the spectrum, you have states similar to Alabama, which does not prohibit physicians from being employed by a corporation as long as the physician is free to use his professional judgment in making medical decisions. This is evidenced in their statutes and opinion letters from the attorney general’s office. You also have states such as Idaho where the board of medicine previously adhered to the doctrine. However, in 2016, they affirmatively rejected the doctrine and would no longer discipline their licensees for practicing in a corporate structure. 

On the other end of the spectrum, you have states such as California. The state statutes clearly prohibit the practice of medicine by corporations and the California Medical Board actively polices and enforces it. The California Medical Board even offers a resource page of their website to address the subject. These states and others like them provide medical spas with clear information on the types of business structures permitted.

Other states may have lax or infrequent enforcement of their prohibition. Wisconsin is an example: the state laws clearly prohibits laypersons from employing physicians to provide medical services as outlined in a Wisconsin Attorney General letter available here. However, there appears to be no recent history of enforcement actions for violating this rule. Wisconsin isn’t alone; many other states have infrequent enforcement of their corporate practice rules. This can create a lurking issue for people wanting to open a medical spa.   

Those preparing to enter the medical spa field may look around and see examples in their state of non-physicians hiring on medical directors or partnerships between doctors and non-doctors.  Depending on the state, these arrangements may be completely fine or they may be in violation of that state’s laws. Where there is lax or infrequent enforcement by the state’s attorney general or the medical board, a medical spa may go years without issue. However, the risks still remain.  Future attorney generals or medical board members may change their policies and begin aggressively bringing enforcement actions. Or, if the medical spa or physician is brought to their attention for other reasons, the corporate structure may result in additional penalties or discipline. The improper business structure could be used as a challenge to contracts in disputes among business partners.

Just like you still wear your seatbelt even though you don’t plan to be in a car accident, having the proper corporate structure for a medical spa is important, even if no one has recently gotten in trouble over it. As the aphorism on ounces of prevention goes, taking time to structure your medical spa correctly at the beginning can be good insurance against possible future issues. If you would like to learn more about medical spas business structures and other legal issues please consider attending an upcoming AmSpa Boot Camp or the 2019 Medical Spa Show.

 

Tags:  Med Spa Law  Med Spa Ownership 

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Trademarks: How to Make Your Mark With Your Med Spa's Name

Posted By Administration, Friday, October 26, 2018

By James M. Stanford, JD, Partner, ByrdAdatto

What’s the first thing most people will know about your med spa? The name! The strategy in naming and branding your business can have a major impact on building goodwill and a contributing factor in the success of your business. You will want to differentiate yourself from your competitors and standout, especially if you’re facing a saturated market place.

Clients frequently seek legal counsel to protect their business’s name and to further understand if their business name may also serve as the basis for a trademark. While a business or trade name is somewhat of a different animal than a trademark from a legal perspective, there are parallels between the two concepts in terms of what strengthens or weakens a business or trade name and a trademark.

Entrepreneurs routinely select very descriptive names for their businesses and trademarks. From a legal protection perspective, however, this can be problematic, as the applicable laws are not designed to protect descriptive or generic names or terms. Stated differently, the names or marks in these instances tend to exactly describe the services or products being provided. For example, you have developed an amazing line of unique and organic cupcakes so you name your business Laura’s Organic Cupcakes or Organic Cupcakes of Texas. If you want protect the name and keep others from using the same or a similar name or mark, these are probably the worst choices for a business name or trademark.

Marks that identify or describe a product or service, are in common use, or are used as geographical indications generally cannot be registered as trademarks and will remain in the public domain for use by anyone. Descriptive trademarks can only be registered if they have acquired distinctiveness after years of continued use and recognition by consumers. Generic terms used to refer to the product or service itself, however, cannot be registered or protected as trademarks.

An entrepreneur should resist the compulsion to describe the goods or services they are offering when selecting a name or trademark. Instead, create a name or mark that is novel and unique. An excellent real-life example of a strong mark consistent with our hypothetical above would be Sprinkles®–a well-known and successful bakery that focuses on cupcakes.

Before you spend a lot of time and money selecting a name or mark for your new business or paying a graphic designer to develop a logo to go with the name, you should speak with experienced legal counsel. Otherwise, you may experience the same frustration many others have faced when they are told their business name or mark can’t be registered or otherwise will be afforded little to no protection.

For more ideas on how to build a profitable and legally compliant medical spa attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

James M. Stanford is an attorney and partner at the ByrdAdatto law firm. From transitions, mergers, and acquisitions to structuring complex ownership arrangements, James enjoys the personal reward that comes from bringing parties together and making deals happen. James practices primarily in the areas of health care and corporate law with a focus on intellectual property. A proud father, Jim served in the U.S. Army and is fluent in Russian. In his spare time, he enjoys hunting, fishing, and spending time outdoors. 

Tags:  Business and Financials  Med Spa Law  Med Spa Ownership 

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Patient Privacy in Your Medical Spa Marketing

Posted By Administration, Thursday, October 25, 2018

By Alex Thiersch, CEO of the American Med Spa Association

Medical spas must use marketing best-practices to succeed, but must also be aware of common patient privacy issues that could leave the practice in hot water. All of a medical spa’s operations must be overseen by both an innovative business eye and a careful, meticulous medical eye. When it comes to marketing, these two perspectives can clash and, if this clash breaches patient privacy, the business can be hit with severe penalties.

Fines for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA) can be huge, and most states have patient privacy laws that are even stricter than the federal standard. Patient information can include—but is not limited to—email addresses, birth dates, social security numbers, and treatment information. Even the fact that a patient is being treated at your facility can be considered private information.

This is not to say that you shouldn’t engage in marketing; you absolutely should. Digital marketing and social media in particular are cost-effective ways to increase the reach of your business. Problems arise when the drive to grow your client base mixes with the unfamiliarity of or neglect of laws and regulations. 

Common Patient Privacy Mistakes
  1. Publicly reaching out to a patient. Engaging with clients is a central tenet of social media marketing. You want to create a sense of connection and community. You must remember, however, that in a medical spa your customers are also patients. Commenting publicly to a client on social media in order to thank them for coming in, or reminding them of a future appointment, or discussing their treatment in any way are all potential breaches of that patient’s privacy.
  2. Responding to comments whether positive or negative. This is risky for the same reasons as listed previously. If patients comment about an experience they had at your business, responding to them can be seen as breaching their privacy, and responding to negative reviews can be especially risky. If, in your response, you inadvertently reveal any private information, then not only do you have a customer who is angry with you, but you also have a customer that can report you for a privacy breach in an industry where investigations from regulators are largely driven by customer complaints. The Washington Post looked into this issue earlier in 2016 and made note of several situations where responses landed businesses in regulatory hot water.  “The consumer complained to the Office for Civil Rights within the U.S. Department of Health and Human Services, which enforces HIPAA. The office warned the dentist about posting personal information in response to Yelp reviews.” The Post further notes that the Office for Civil Rights, “is currently investigating a New York dentist for divulging personal information about a patient who complained about her care, according to a letter reviewed by ProPublica.” Do yourself a favor and don’t respond to negative reviews.
  3. Publishing photos without proper consent. Before-and-after photos are a powerful method of attracting new patients. Without the proper signed consent forms, however, you cannot publish patient photos to your website, blog, social media, or any other platform. Additionally, if you post photos of your facility or an event at which you’re offering treatments, you should be very careful to ensure you are not publishing a photo showing any patient in the background who has not signed a consent form.
What Can You Do?

The No. 1 rule when mixing marketing with medicine is you must be informed. The defense, “I didn’t know what the law was,” never works. Medical spas are governed by several different licensing boards and a slew of individual laws that vary from state to state, so be sure to consult a health care attorney (preferably with experience with aesthetics) that is familiar with the laws in your state. Know the regulations that apply to your business, and err on the side of caution.

As far as concrete things you can do, keep the following in mind. 

  1. For treatment reminders and thank-yous, a personal email or phone call should be used in place of reaching out via social media. 
  2. Consent forms are a necessity when displaying any photography of patients or of medical procedures on any platform, and be sure to note that traditional consent forms for before-and-after photos are not necessarily sufficient for using photos on your social media channels.
  3. The best ways to fight bad reviews are providing superior patient care and encouraging your happy customers to post positive reviews.

Also, keep in mind that once you understand what you need to do to protect your patients’ privacy in your marketing, you must train your staff to do the same. Your staff must know the regulations as well as you do, since you will be on the hook for any breach. Establish marketing procedures and guidelines, have them in writing, and make sure your staff knows them backward and forward.

For more ideas on how to build a profitable and legally compliant medical spa attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

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

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Why Is It So Hard to Find Legal Answers in This Industry?

Posted By Administration, Tuesday, October 23, 2018

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

We at AmSpa and ByrdAdatto are constantly asked for information regarding the legalities of the medical aesthetics industry. Every day, we hear from professionals wondering, for example, why a registered nurse can perform one procedure but not another, or why a licensed vocational nurse can inject one substance but not another. 

Providing information such as this to industry professionals is the reason why AmSpa was started in the first place, but we often get pushback from people who question our conclusions or wonder why, if the law is what we say it is, no one is following it. The truth of the matter is that finding legal answers in the medical aesthetics industry is not easy, and there are numerous reasons why.

Certain conversations regarding the legalities of the industry happen over and over again. For example, I will explain to someone about the requirement that a physician, physician assistant, or nurse practitioner perform a face-to-face exam of a patient before a laser treatment or filler injection, and the person with whom I’m speaking will say that can’t be true—nobody does that. If that were the rule, they say, you could shut down every medical spa in the state. But it is true, it is the rule, and yes, you probably could shut down most medical spas in any given state if you had a mind to. 

The medical aesthetics industry is unique for a few reasons. First of all, everything is elective, so you’re marketing to people who choose to undergo a particular procedure rather than require it. Also, medical spas do not deal with insurance—it is a cash-based industry. Because of these factors, medical spas have to engage in marketing in ways that more traditional medical outlets don’t typically have to consider.

As a result of this emphasis on marketing, non-physicians play a key role in the health of these businesses. For example, a registered nurse who is a phenomenal injector can be the person patients come to see, as opposed to the physician. This is a much different dynamic than you are going to find anywhere else in the world of medicine.

Additionally, medical aesthetic practices have to deal with multiple practice groups, including medical boards, nursing boards, and boards of cosmetology. And because the medical aesthetics industry is so new, many of these agencies are dealing with the issues raised by its practice for the first time. Essentially, the industry is being governed by laws that are not designed to govern it and people who are largely concerned with more pressing issues.

For example, representatives of a nursing board probably don’t have many thoughts about CoolSculpting, since much of their time is spent dealing with pressing matters such as opioids. They have so much going on that they can’t reasonably be expected to understand the nuances of the medical aesthetics industry.

When AmSpa researches the laws that apply to medical aesthetics practices in a particular state, we start by looking up what we can in the state’s legislation, but nine times out of 10, these laws’ application to medical aesthetics situations is tangential. They’re typically written to deal with other areas of medicine and nursing. Therefore, the boards’ interpretation of these laws with regard to medical aesthetics is of the utmost importance. If a board has no published opinion on a matter, that doesn’t necessarily mean that it doesn’t have an opinion—it just means that they have not yet presided over an incident that has caused them to issue an opinion. When you’re dealing with multiple boards with multiple opinions, it complicates things further.

All this makes AmSpa’s job very difficult. Much of the time, we have to take what we know about the laws and the boards and try to pinpoint what a ruling would be. When we say, “This is what we believe the rule is in this particular state,” it’s probably not taken directly from legislation, because that legislation likely doesn’t exist. We can, however, combine precedents with our legal knowledge to give you the best read on the situation possible.

Our attorneys have been researching these decisions for years. They have gone before nursing boards and medical boards to argue cases, and they have talked to officials about these issues. This is how we find out this information. It’s very difficult, but we’re confident that our attorneys offer our members the best possible information. 

For more information about med spa laws, become an  AmSpa Member to schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  Business and Financials  Med Spa Law 

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What the FDA Warning on Vaginal Rejuvenation Devices Means to You

Posted By Administration, Wednesday, October 17, 2018

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

On July 31, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a statement that announced the agency was concerned laser manufacturers were marketing their products for use in vaginal rejuvenation, a treatment that has become a sensation in the medical aesthetics industry in recent years. The agency cites “numerous” adverse outcomes as a driving factor in bringing this issue to light.

“As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts),” said Gottlieb in the statement. “But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’ In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

Elsewhere in the statement, Gottlieb mentions seven laser manufacturers who have been contacted regarding this issue—Alma Lasers, BTL Industries, Cynosure, InMode, Sciton, Thermigen and Venus Concept—and suggests that they could face sanctions if the agency’s concerns are not addressed to its satisfaction.

The statement has been covered by numerous media outlets and has drawn a great deal of mainstream attention to the procedure and the issue. But what is the issue, exactly, and do medical spas have anything to fear from providing vaginal rejuvenation and other procedures that are not directly specified by a device’s FDA approval?

Off-label, Not Off Limits

In most cases, it is perfectly legal for a physician to use FDA-approved medications and equipment in ways that are different from what the label specifically mentions, which is referred to as “off-label use.” It typically is up to a doctor’s own medical judgment to determine if a medication or tool can be used for other treatments. According to Jay D. Reyero, JD, partner with ByrdAdatto, a national law firm that focuses on medical aesthetics, “The FDA does not control a physician’s ability to prescribe off-label, as it is subject to the oversight of the applicable medical board.” All the lasers in question have been approved for use in the United States, albeit not specifically for use in combating particular conditions.

To hear more from Mr. Reyero on the subject listen to him elaborate on the topic on the Medical Spa Insider podcast.

“The lasers have been FDA-cleared for ablation and laser treatment of skin of various different parts of the body, including genitourinary tissue, as per the FDA clearance letter,” says Peter Castillo, MD, FACOG, director of the Women’s Pelvic Health Institute in Los Gatos, California. “But what they have not cleared it for is for other conditions as of yet. That takes time and various studies—well designed, randomized multi-center trials—to really accumulate enough data.”

Castillo sees Gottlieb’s statement as a reminder to manufacturers and doctors that lasers that are not approved specifically for vaginal rejuvenation treatments—and there are none at this point—should not be marketed as if they are, despite their actual efficacy.

“The letter’s primary purpose, the way I see it, was really just to remind physicians that they are not allowed to and should not promote the use of these lasers for the conditions that they are stating, though that does not really mean that they’re not effective treatments,” Castillo says.

Castillo cites the precedent of Botox, which originally was specified by the FDA for use in the treatment of incontinence caused by spinal cord injuries or multiple sclerosis, migraines, upper limb spasticity, pain caused by cervical dystonia, axillary hyperhidrosis (sweating), blepharospasm (eye spasms) in children with dystonia, and strabismus (crossed eyes) in children. The reduction of facial wrinkles is nowhere on this list, but it became by far the most common use of the drug and, subsequently, Botox has received three indications for cosmetic use. “Botox had been used off-label for a decade before it got clearance,” Castillo explains. “The difference is that [Botox manufacturer] Allergan did not market it as an off-label use—they cannot. [Gottlieb’s statement], unfortunately, was needed, and it was necessary to put some of the manufacturers back on track and realizing that though that may be the case and perhaps this will be a viable treatment in the future, they’re not FDA-cleared for that and, as of yet, should not be marketed as such.”

Reining In the Rhetoric

This is not to say that Castillo agrees with everything in Gottlieb’s statement, however. Castillo is involved in clinical testing of laser equipment used for vaginal rejuvenation, and says that, in his experience and that of his colleagues conducting similar trials, the complications mentioned in the statement—including “numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain”—are extremely uncommon.

“None of us have seen the level of complications that they alluded to in the statement, and no one that I have spoken to and none of us in our study groups have ever seen them outside of anticipated or expected effects of laser treatments,” he says. 

“There is growing data. A variety of studies are going on, they are being carried out right now, and they have demonstrated very effective results and safety profiles for a variety of these lasers.”

According to Reyero, “Physicians who are performing vaginal rejuvenation or who are interested in providing vaginal rejuvenation should have a good understanding of available scientific and clinical data relating to the procedure in order to, in their professional judgment, determine it safe for patients.” Castillo feels that in the statement, Gottlieb exaggerates the potential risks of vaginal rejuvenation, and he is concerned that coverage by media outlets that picked up the story could scare people away from what he feels is a largely safe, very beneficial treatment.

“I think that statement from the FDA lost its purpose when they overstated the risks involved in using laser therapies that they’ve already cleared for use of skin ablation,” Castillo says. “Unfortunately, the purpose of it gets lost, and the message that resounds with these inflammatory statements by a variety of papers or other parties that are quick to jump on the potential risks that they stated and expanding on them to make it sound like people are getting harmed by these and that we shouldn’t be doing them.”

Reyero says, “I think physicians can combat any negative reaction to the FDA’s statement by equipping themselves and their staff members with information needed to ensure patients are fully informed and understand the risks about the procedure just like any other medical treatment.”

Results

Despite the large amount of press coverage the statement has garnered, Castillo says that the hubbub has not had an adverse effect on his practice. Quite the opposite, in fact.

“The important thing here is that demand continues,” Castillo says. “The outcomes are real. They are palpable to the patient and to the provider, and it’s driven attention to a need and to a demand that’s being unmet. I have not had any decrease in my requests for therapy and I haven’t changed my practice, which has always been based on my clinical interpretation of their needs and patient selection. Those who practice medicine in the way they should are guided by clinical principles and clinical judgment. I see this as a continuing benefit to women and a service that we should continue to provide. And in time, the amount of data necessary to request clearance for those specific conditions and disease states will come, like everything else.”

According to Reyero, “I think the FDA letter will serve as a good push to those performing the procedure to reevaluate their practice and confirm that they are compliant with applicable rules. From advertising to patient education to the performance of the procedure itself, every facet should be carefully vetted so providers feel confident they have done all that is required to uphold the standard of care.”

Vaginal rejuvenation continues to grow in popularity, and patients are largely very satisfied—users of RealSelf.com currently express a 95% “worth it” rating for the procedure, which is impressive given its relatively high cost. However, laser equipment manufacturers should practice restraint when marketing products that are used for this treatment. Drawing unwanted attention from a governmental agency is never a good idea, and in this case it can easily be avoided by paying attention to what is and isn’t allowed. Gottlieb’s statement may overstate the problems associated with vaginal rejuvenation, but it should still be seen as a wake-up call for both equipment manufacturers and physicians.

For more information see the joint statement on this topic issued by the American Med Spa Association and the law firm of ByrdAdatto.

Tags:  Med Spa Law 

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Do You Need a License?

Posted By Administration, Monday, October 15, 2018
Updated: Monday, October 15, 2018

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

Med spas in their quest to provide the best beautifying services to their clients straddle the line between medical procedures and traditional cosmetic treatments. So it is no surprise that traditional salon cosmetic procedures are major part of a med spa’s business. In fact, according to the 2017 Medical Spa State of the Industry Report, aesthetic and cosmetic procedures are the 2nd most common procedure done in med spas and are the 2nd best revenue generators. 

Traditional aesthetic procedures compliment the medical treatments offered by med spas, and since these are not medical procedures they don’t require physician supervision. Similarly they don’t require a medical or nursing license to perform. And most of the procedures don’t require the huge capital investments needed for machines such as laser or IPL devices. However, choosing to offer traditional aesthetic procedures does come with its own set of complications.

As you know med spas are medical practices and need to follow the regulations for medical practices. It follows then that med spas that offer salon treatments fall under spa and salon regulations, too. In some states a medical practice that offers aesthetic procedures through cosmetologists or aestheticians needs to also have their facility inspected and be licensed as a salon.

For instance, in California the Board of Barbering and Cosmetology requires that places offering cosmetology and aesthetician services must obtain an establishment license for the premises in addition to the practitioners holding their own cosmetology or aesthetician licenses. Similarly, in Texas aestheticians are only permitted to practice their art in licensed salon or cosmetology facilities. Typically, to obtain these licenses the facility must meet certain square footage, restroom, and sanitation requirements. This shouldn’t be an issue for most med spa locations but it is prudent to review the regulations for salons to avoid any future issues. You wouldn’t want to finish your build out only to find that one of your rooms is 5 square feet too small. 

If you plan to offer permanent make up or micropigmentation services you will want to check with your state’s tattooing or body art board. Permanent makeup is generally considered a form of tattooing and requires a tattoo license for the artist and usually must be performed in a licensed tattoo parlor. A few states have specific permanent cosmetic or micropigmentation licenses separate from their tattoo license.

While in many states physicians are given an exemption from needing a tattoo license this is not always the case, and even if a physician is exempt that doesn’t necessarily mean the med spa or other employees are. For instance, in Mississippi the exemption is only for the physician and doesn’t extend to delegated health professionals and the facility still needs to be inspected and licensed as a tattoo parlor.

If you are thinking of hiring an aesthetician or want to expand the “Spa” side of your med spa be sure you get the needed licenses. If you have questions about what licenses your med spa might need please contact us. AmSpa members receive an annual compliance consultation call with the law firm of ByrdAdatto.

Has your spa started offering more salon services? What are your most popular procedures? We want to know; data collection for the 2019 State of the Industry Report will be opening soon and we hope to hear from you. 

Tags:  AmSpa's 2017 Med Spa Statistical Survey  Med Spa Law 

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Medical Provider Health Care Laws and Your Med Spa

Posted By Administration, Friday, October 12, 2018

By Michael S. Byrd, JD, Partner, ByrdAdatto

Is your med spa compliant with health care laws and regulations? Owners and operators of a clinical practice must navigate traditional business and employment laws similar to any other business. On top of this, clinical providers must operate in the heavily regulated and often confusing world of health care laws. The following is a list of the primary health care laws and regulations that affect providers:

  • Patient Protection & Affordable Care Act
  • Affordable Care Act Implementation
  • Out-of-network Referrals
  • Medicare-Medicaid Anti-Fraud & Abuse Amendments
  • Anti-Kickback Statute
  • Management Service Organizations
  • Anti-Referral Regulations (Stark II)
  • The False Claims Act (FCA)
  • Increased Joint Venture Activity and Market Consolidation
  • Occupational Safety and Health Administration Regulations (OSHA)
  • Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
  • Physician Payments Sunshine Act (Sunshine Act)

The essence of almost all health care law is patient protection. Because of this, many traditional business strategies are problematic or even prohibited in health care. We do not advise our clients to memorize each of these laws. At the same time, the “head in the sand” strategy to avoid health care compliance does not usually end well.  Communicating business arrangements and strategies with your counsel are key to compliance.  Most health care compliance problems stem from a lack of knowledge of the law and lack of communication with counsel regarding the activities of the clinical practice.

Compliance in healthcare requires a commitment. While ByrdAdatto can prepare a plan or structure an arrangement to navigate compliance obstacles, compliance does not end with the documentation. Rather, health care compliance starts with the documentation and continues with the day to day operation of the practice.

For more information on your state’s laws and regulations, attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

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

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