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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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OSHA: What You Don’t Know Can Hurt You

Posted By Administration, Thursday, October 11, 2018

By Alex R. Thiersch, Founder and Director of the American Med Spa Association

Med spa ownership, delegation requirements, HIPAA, and fee-splitting are common issues to consider when coming up with your medical spa’s compliance plan, however it is vital that you do not overlook Occupational Safety and Health Administration (OSHA) standards in your medical aesthetic practice. You may not even know what OSHA is, what it does and why it does it. It’s time to change that. In fact, it’s mandatory that medical spas follow OSHA standards—your business depends on it.

When Lori Marshall, a physician's assistant at the West Side Medical Spa, reported to management that she had been stuck by a contaminated needle during a procedure, nobody knew what to do. When she tried to convey to management the need for procedures, she was told to wash the puncture site and get back to work. Lori felt betrayed and angry. At her husband’s suggestion, Lori called the Occupational Safety and Health Administration (OSHA) and reported the incident. Within hours, Lori was contacted by an OSHA compliance safety and health officer (CSHO), who took a detailed statement from Lori, and advised her that they would schedule an immediate site visit.

Two days later, an OSHA CSHO walked in to the West Side Medical Spa and identified herself to management, and advised that they were there in response to a complaint. Throughout the next three days, all employees were interviewed, and all documents and records were reviewed.  Within a matter of weeks, West Side Medical Spa received a letter containing the following citations and penalties.

No written bloodborne pathogens/exposure control plan                             $4,500 
Failure to train employees in BBP within 10 days of hire                               $2,500
Failure to provide medical follow-up after an exposure                                $2,500
Failure to maintain required needle stick logs                                                  $1,500
Failure to include employees in selection of safe medical devices             $2,500
Total penalties                                                                                                    $13,500

 
This scenario is based on an actual event, and all names have been change to avoid actual identification of the employee or the employer. 

What is OSHA?

The Occupational Safety and Health Administration (OSHA) is part of the United States Department of Labor. It was created by the Occupational Safety and Health Act of 1970, and its mission, according to the act itself, is “to assure safe and healthful working conditions for working men and women.” OSHA protects most private-sector workers in the United States, though its standards are typically associated in the public consciousness with industries such as construction and agriculture—fields in which physical labor is a major part of jobs, and workers may easily suffer injuries—or worse—if improperly trained.

However, medical spas and medical aesthetic facilities also must follow a number of OSHA standards, which may come as a surprise to their owners and operators. Often, unless these are followed, a business can be fined tremendously and ultimately, it can be shut down.

“Sadly, many medical spas may not even be aware that OSHA standards apply to them,” says Steve Wilder, president of Sorensen, Wilder & Associates, a safety and security risk management consulting group specializing in health care. “Medical spas are considered health care entities; therefore, they are subject to the health care requirements of OSHA.”

OSHA standards for medical spas

According to Wilder, medical spa owners and operators must comply with seven particular OSHA standards.
• Bloodborne pathogens—exposure control plan;
• Hazard communication;
• Recordkeeping;
• Slips, trips and falls;
• Tuberculosis;
• Workplace violence; and
• Laser safety.

The specific requirements for each standard can be found on OSHA’s website (www.osha.gov). In general, compliance for each standard requires commitment from management and employees; workplace analysis; detailed hazard prevention and control procedures; the completion of training programs; and detailed recordkeeping utilizing OSHA’s Form 300 log and Form 300A summary.

“If you’ve got the proper programs in place in those seven areas, including the written programs, the training programs and everything that’s required, you’re going to be in pretty good shape,” says Wilder. “It can be expensive, but there are a lot of alternate ways around it. You can find different ways to be creative—such as online training—and still meet the intent of the requirement.” 

What Happens If I Do Not Comply?

If OSHA conducts an audit on your medical spa and finds that it is in violation of workplace standards, you will be fined a considerable amount.

“OSHA has enforcement authority under the federal government,” says Wilder. “The standards that they develop can be enforced under penalty of law. What that means is that if they come in and audit a health-care provider—whether it’s a spa, hospital, nursing home, an ambulance or whatever—and they identify places in which the health-care provider is not compliant with the standards, they then have the authority to issue monetary fines.”

And those fines can be severe. OSHA can issue a fine of up to $7,500 for a first offense, though it is more likely that such a fine will be in the range of $1,500 to $5,000, depending on the severity of the deficiency. It is also important to keep in mind that each additional violation will result in an additional fine, and these fines can quickly add up. What’s more, you cannot be insured against such fines, so they will come directly off of your bottom line.

“I looked at [a case] for a nursing home client a couple of months ago and, when OSHA got done with them, their total penalties were more than $45,000,” explains Wilder. “And with no insurance to cover it, that’s a heck of a bite.”

And if a violation for which you have already been cited is found during a subsequent visit, or if said violation is found at a different location that is owned by the same person or company, OSHA has the authority to fine you up to $75,000 for that violation.

“You need to take it seriously,” cautions Wilder. “OSHA is not getting any gentler; they’re not getting any more workplace-friendly. Expect them to be really aggressive in infection control in all areas of medical care. Their focus is protecting employees, so anywhere that employees can get exposed to an injury risk or to an illness risk, they’re aggressive about it.”

Knowledge is Power

Bringing your medical practice up to OSHA code is not an option. It’s a necessity and OSHA does not accept ignorance as an excuse. Now that you know what is expected of your business, you must take the necessary steps and move forward in order to avoid major financial penalties that very easily could result in the closing of your business. Click here to read more articles about med spa law topics and how they could affect your business.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn ways to build and run your medical spa practice profitably, and within the bounds of the law.

 

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

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The Med Spa Industry Needs Minimum Standards, and It Needs Your Help to Make It Happen

Posted By Administration, Wednesday, October 10, 2018

By Alex Thiersch, JD, Founder and Director of the American Med Spa Association

AmSpa has been watching the medical aesthetics industry grow for five years, and I’ve personally been involved in compliance issues involving the industry for more than 10 years. In that time, I’ve continually observed a total inconsistency across states and practices regarding who is doing what procedure and the risk that is incurred with that, and it both amazes and disappoints me.

There needs to be some minimum standard that all medical spas follow. The reason I’ve become concerned about this is because, recently, I was interviewed for a story that will be published in the coming weeks, and the author asked a lot of pointed questions about the industry—she wanted to know about people getting injured, unsafe practices, lawsuits, regulations, and so forth; this is the third or fourth time in the past year that these issues have come up. However, I continue to see medical spas that are doing things that they just should not be doing, and it harms the entire industry.

Self-regulation is the only way for the industry to stop this, and AmSpa wants to help lead the way by creating some minimum standards that everyone can buy into. However, the only way this is going to work is if the entire industry buys into it.

One of the reasons I’m bringing this up relates to injectables. We have had an ongoing discussion with aestheticians, medical assistants, and practical nurses—basically everyone who is not an RN or above—about whether or not they should be performing injectable treatments. Most states basically allow doctors to delegate these treatments to whomever they want, but that doesn’t necessarily mean that aestheticians should be injecting. 

In fact, my law firm, ByrdAdatto, and AmSpa have been steadfast in the opinion that only nurses and above should be performing these procedures, and we think that needs to become a rule. If patients get injured because non-licensed professionals are performing erroneous procedures, the industry is going to be legislated out of existence.

It is my strong belief that if the industry regulates and sets minimum rules, the industry will become bigger, because it will create standards and safety, and end the particularly egregious accidents that are happening.

To that end, I am happy to announce that AmSpa is embarking on a project to create minimum standards, including, but not limited to items such as:

Who can perform certain treatments;
Training standards; 
Ownership standards; and 
Supervisory requirements. 

However, it is only going to go so far unless practices get on board with regulation. There can’t continue to be stories of people getting injured and medical spas being shut down because they are not following proper medical protocols. All this has got to stop. Until it does, this industry is only going to go so far, and possibly could even go in the opposite direction.

If you think this can’t happen, look at the National Football League, which is going through a major shift because people are finally beginning to realize how dangerous the game is due to emerging stories about the effects of chronic traumatic encephalopathy. More and more parents are not allowing their children to play football, and who knows what will happen to the game in 20 years.

We’re asking for everyone’s help with this initiative. It’s not only important—it’s crucial. I sense there is blood in the water when it comes to media coverage of the medical aesthetics industry, because we’re getting contacted more and more often by reporters and authors who are working on negative stories, and industry professionals have got to do whatever they can to protect themselves.

 

Stay tuned for information in the coming months regarding standards in the medical spa industry.

Tags:  Business and Financials  Med Spa Law 

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Can RNs Inject Botox in Florida? The Nursing Board Says… It’s Complicated

Posted By Administration, Tuesday, October 9, 2018

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

The question of who can inject Botox and fillers in a medical spa is one of the most common in the industry, and for Florida it seems that the answer may be more strict than in many other states. Botulinum toxins (i.e. Botox, Dysport, or Xeomin) and injectable fillers are year after year one of the top procedures performed in med spas and they are consistently among the top procedures sought by patients. This popularity is the case in Florida as well. But who can perform Botox and dermal filler procedures in Florida? 

Can Physicians? Yes, physicians are licensed to diagnose, treat and prescribe for any human disease or injury. Physician assistants can as well if their supervising physician delegates the practices in a written protocol. Nurse practitioners may also perform botulinum toxin injections if authorized by their supervisory protocols. What about registered nurses (RNs)? Well... let’s look at the law.

Florida Board of Medicine
According to the Florida Board of Medicine there are no laws or rules that directly address who may or may not inject. RNs must practice within the scope of practice of their license as described in the Nurse Practice Act. Registered Nurses are licensed to practice “professional nursing” which is defined as, among other things, 
“the administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments.”

Based on that it would seem that RNs should be able to perform these treatments. After all, physicians definitely can prescribe and inject toxins and filler and these are certainly either a medication or treatment (or both). But the answer is not so clear from the Florida Board of Nursing.

A Challenged Rule

According to a 2015 administrative hearing which you can read here, the Nursing Board had an answer to a frequently asked question on their website. It read 

“Can a practical or registered nurse inject Botox? The injection of Botox is not within the scope of practice for practical or registered nurses and does not constitute the administration of medication”.

The hearing in question was challenging the validity of the statement on the grounds that it constituted a “rule” that was adopted in violation of Florida’s rulemaking procedure statute. The final order found that rule had indeed been adopted in violation of the statute and prohibited the Board from relying on the statement (or similar statements) as a basis for disciplinary actions. That was in March of 2015, and the “Botox FAQ” no longer appears on the Board’s website, and it doesn’t appear that an administrative rule was passed since then. 

The Supervision Question

In February of 2017 we have a disciplinary action made against an RN for injecting Botox without a physician’s order, which you can read here. This makes sense as an RN is permitted to administer treatments and medications when authorized by the prescribing practitioner. 

Based on that ruling, hypothetically, if this RN had a valid physician’s order she would not have been subject to discipline, so we have a better idea of the Board’s stance as to what an RN needs to do to inject Botox versus the 2015 blanket statement. 

But not so fast! 

We have an order issued later that same year from a request for a declaratory statement in October of 2017. You can read it in full here.. In it, the RN stated they had training in injecting Botox and dermal fillers and provided two certificates from training courses. The RN intended to provide Botox and dermal filler treatments under the supervision of a physician. On the face of it this seems promising: we have an RN with training in a procedure getting physician’s orders to do the procedures. It should meet all of the tests to fit within the RN’s statutory scope of practice. 

However the Board decided that, no, the RN was not permitted to do this. In the order they draw a distinction that “aesthetic injections” are not part of the scope of practice for RNs. It should be noted that declaratory statements are the Board’s opinion regarding the requesting nurse’s specific situation and may not be applicable to other sets of facts.

So Where Does That Leave Us? 

It seems the Board of Nursing has an unwritten policy that RNs cannot inject Botox or dermal fillers even when under the supervision of a physician and with specific training and education. It is true that “injections for aesthetic purposes” are not specifically authorized in an RN’s scope of practice, but likewise there is nothing specifically forbidding the practice or declaring toxins, fillers, or “aesthetic injections” not a medicine or treatment. So Florida registered nurses are left in limbo as to what they are actually permitted to do with their license. 

Plainly reading the statutes points to a different answer than the Nursing Board has been giving. AmSpa and partner law firm ByrdAdatto are reaching out to the Board for clarification and will post the information as soon as it is available.

Tags:  Med Spa Law  Med Spa Ownership 

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Keys to Keeping Medical Records in a Medical Spa

Posted By Administration, Monday, October 8, 2018

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

Medical spa medical records are a piece of your compliance plan that cannot be overlooked. It’s easy to look past them when considering other parts of building your business, but they are vital to your practice. According to our 2017 State of the Industry Report med spas indicated that 70% of their clients are repeat customers. This is a wonderful statistic to read because loyal customers are happy/satisfied customers and they can and will generate great recommendations and buzz for new customers. But these loyal clients and customers are much more than that; they are also patients. Because most of the procedures offered in med spas are medical procedures the practice must retain appropriate records just as any other clinic or doctor’s office would. 

The content and retention requirements for medical records are set by each state and their respective medical boards. In general the records should include, among other things, medical histories, exam notes, details of procedures and treatments. Typically these should be kept for several years after seeing the patient with the two years that New Mexico requires being the shorter side and 10 years as in Tennessee and South Carolina being on the longer side. Physicians may be subject to Board discipline for failing to properly maintain and keep patient records, so you will want to review your own state statutes and advice of your medical board to determine what information should be kept in the medical records and how long you should keep them. 

Watch AmSpa’s webinar on patient charting for more information on the topic.

The 2017 industry survey also uncovered this interesting stat: half of med spas we heard from see more than 50 patients a week. This is great from a business perspective, but daunting from a record keeping perspective. Every one of those visits will need an entry made in that patient’s records, and the med spa’s records system, in addition to being able to keep up with the volume of updates, will also need to comply with Federal and State privacy laws. 

The big one is the federal Health Insurance Portability and Accountability Act (HIPAA). I’m sure you’ve heard more about HIPAA than you ever cared to so I won’t bore you with too much detail other than to say patient medical information needs to be securely stored and accessible only to authorized individuals. Most states also have a version of a patient information privacy law with similar concepts. 

While the general gist of the laws are “protect patient information” you’ll need to check your jurisdiction for specific implementation requirements. For instance California has the Confidentiality of Medical Information Act which has stricter requirements on when and who you can disclose confidential health information. AmSpa members can check their state’s medical aesthetic legal summary, or utilize their annual 15-20 minute complimentary compliance call with ByrdAdatto for more specific information.

It takes a lot to build a successful med spa and the more successful it becomes the more important it is to have a streamlined and secure medical record system and policy. Don’t let paperwork be a limitation on your Spa’s success. If you want to learn more about record retention policies and systems consider attending one of AmSpa’s Medical Spa & Aesthetic Boot Camps to learn medical spa legal and business best-practices.
 
If you liked reading through our 2017 State of the Industry Report we will be gathering data for 2019 survey soon. Did your spa see more customers this year? Did you add new service lines? Or bring on more staff? We hope to hear from you so together we can define data in the medical spa industry.

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

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Telemedicine Law: What the Delaware Update Means for Your Med Spa

Posted By Administration, Friday, October 5, 2018

By Brad Adatto, JD, Partner, ByrdAdatto
 
There’s a new rule concerning telemedicine in Delaware that could potentially affect you and your practice. On June 1, 2018, the Delaware Board of Medical Licensure and Discipline (“Board”) issued a rule to clear up some important issues in the Delaware telemedicine law surrounding patient exams and prescriptions. Telemedicine promises to leverage telecommunication technology to improve delivery and efficiency of medical care. However, it is not risk free. Without the traditional in-person patient exams, the possibility of abuse and less attentive care is increased. To combat this concern, Delaware enacted a telemedicine law in 2015 that lays out a framework for appropriate telemedicine implementation.
 
The law requires that before a physician can first diagnose and treat a patient via telemedicine, they must have formed a patient-physician relationship and perform an appropriate exam of that patient. This patient exam can take four possible forms. The first two methods are to either have an in-person exam with the attending physician, or have another Delaware licensed physician present with the patient. While these methods can be effective at overcoming the deficiencies of audio/video meetings, they also remove the “tele” aspect of telemedicine.
 
The third method is to base the diagnosis on audio and video electronic communication. Here the Board has clarified that the audio/video communication must be live and in real-time. This means that the physician cannot rely solely on saved images and data.  Therefore, this particular method, known as “store and forward,” must use some sort of real-time video conferencing.
 
The fourth approved method is for the examination to use telemedicine practice guidelines that have been developed by “major medical specialty societies”. Through this method, the Board is directing Delaware physicians to look to guidelines promulgated by societies that are members of the Council of Medical Specialty Societies to tailor their telemedicine exam policies. You can find a list of members here.
 
Finally, the Board has added a major restriction to prescribing opioids via telemedicine. Physicians practicing through telemedicine can prescribe medications under the same standards they use in their in-person practice. However, the rule prohibits telemedicine-practicing physicians from prescribing opioids unless the prescription is part of an addiction treatment program permitted by the Delaware’s Division of Substance Abuse and Mental Health and performed according to the Division’s guidelines. This restriction should close off a possible avenue for misuse in the face of the opioid epidemic. The Board’s rules follow many other states, such as Texas that passed a law in 2017 with similar rules and regulations.
 
To see how your state handle telemedicine check the AmSpa medical aesthetic legal summary.
 
Hopefully the reduced uncertainty that these rules bring will not only prompt more Delaware physicians to employ telemedicine in their practices but allow more Delawareans to benefit from this cutting edge technology as well. 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.
 
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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FTC Announces Enforcement Action Against IV Therapy Clinic for Misleading Advertising

Posted By Administration, Monday, October 1, 2018

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

The Federal Trade Commission (FTC) recently announced their first ever enforcement action against a provider of intravenous therapy (IV therapy) for making unsupported claims about the health benefits of their IV treatments. You can read the complaint and press release by clicking here. But in brief the FTC alleges that iV Bar’s website contained multiple false, and unsubstantiated representations as to the clinical or scientific effectiveness of the treatments. Setting aside the merit of the FTC’s claims, this case does highlight a hidden danger of medical spa and IV bar ownership: advertising.

Advertising is a critical part of a successful med spa or IV therapy clinic. Effective advertising is vitally important in attracting new patients and informing existing patients of other services you offer. You want to let consumers know of your expertise, the benefits you can provide, and to distinguish your practice above your competitors. However, med spa and IV therapy clinic advertisements, as with other medical practices, fall under several layers of rules and regulations. Since advertising by its very nature is easily accessible out in the public sphere it makes it a simple matter for regulatory bodies to locate advertisements that violate the laws. Therefore it is beneficial for med spa and IV bar owners to have at least some familiarity with the limitations of what they can say in ads.

Read more about legal issues in medical spa advertising here.

Deceptive Practices Acts

In addition to the Federal Trade Commission Act, many states have adopted some form of a deceptive trade practices act designed to protect consumers from fraudulent and deceptive advertising and statements. These are usually enforced by the State’s attorney general and many provide private rights of action allowing the consumer to sue the business directly. For example the Texas Deceptive Trade Practices Act makes it a deceptive practice to represent that goods or services have approval, uses, benefits which they do not. Damages in the Texas statute can include compensation for economic and mental anguish and if the court finds that the conduct was “knowing” and “intentional” it can result in three times the economic and mental anguish damages being awarded to the consumer. 

Medical Licensing Boards

Med spas and IV therapy clinics are medical practices and as such will fall under their state’s rules for physician advertising and professional conduct. Many state Medical Practice Acts, including Florida’s, prohibit physicians from using false, deceptive, or misleading advertising or as is the case in New Hampshire claiming professional superiority. Even if not explicitly in the statutes, state medical board’s ethics rules and opinions often contain similar prohibitions. For a good general overview there are the American Medical Association’s ethics opinions such as this one which states, in part:

Because the public can sometimes be deceived by the use of medical terms or illustrations that are difficult to understand, physicians should design the form of communication to communicate the information contained therein to the public in a readily comprehensible manner. Aggressive, high pressure advertising and publicity should be avoided if they create unjustified medical expectations or are accompanied by deceptive claims. The key issue, however, is whether advertising or publicity, regardless of format or content, is true and not materially misleading.

Often, state medical disciplinary boards are influenced or adopt guidelines similar to the AMA’s.  
The business name you advertise under can also be subject to various rules. Several states, one such being California, prohibit a physician from doing business under a name different than their own unless they obtain a fictitious or assumed name registration. Still other states limit the use of words such as “spa”, “clinic”, or “medical” unless certain requirements are met or procedures offered.

AmSpa members can utilize their annual compliance consultation call with the law firm of ByrdAdatto to understand the medical advertising requirements in their particular state.

Conclusion

False, misleading, and deceptive. If you feel like you are seeing a trend you are right. Generally these laws and boards use similar language to protect consumers and patients. However the specific interpretation and implementation of these terms is not identical and one type of ad or commercial may be acceptable in one state and not in another. So before you launch a “too good to be true” campaign you would do well have it reviewed by your counsel or to read up on your jurisdiction’s advertising rules.  

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn how to build and run a profitable, efficient, and legally compliant medical spa practice.

Patrick O'Brien grew up in west Texas loving the outdoors and Scouting, earning the rank of Eagle Scout. After attending Southwestern University, he worked in Margin trading with a major investment brokerage. There, he saw how yesterday’s decisions affect tomorrow, and learned how to proactively navigate situations to give clients the best possible outcome. This problem solving inspired his return to school and pursuit of a law degree from Southern Methodist University. He brings his legal training and business acumen to AmSpa to get ahead of legislative changes which affect our members. When he is not in the office he enjoys reading the same book to his toddler for literally the twentieth time today. But he laughs every time so it is worth it. He also loves cooking and spending time outdoors with his wife, son, and loyal hound.

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

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Med Spa Law Terms You Need to Know

Posted By Administration, Wednesday, September 26, 2018
Updated: Thursday, September 27, 2018

By Renee E. Coover, JD, ByrdAdatto

As revenues in the medical spa industry increase, so does the enforcement of medical spa regulations. The 2017 Medical Spa State of the Industry Report calculated that the industry was valued at nearly $4 billion with an annual growth trajectory of 8% through 2022. Legally speaking the report found that 37% of practices were not performing good faith exams, 31% were paying commission on medical treatments, and 10% were even relying on laser techs or aestheticians to perform injectable treatments. An expanding industry can present increasing risk for medical spa owners and operators. As the number of medical spas has increased, so has the number of lawsuits filed against them, and because there are few specific rules and regulations governing the administration of nonsurgical cosmetic procedures, there are limited opportunities for training and certification.

In order to protect yourself and your business from exposure to problems such as these, you should familiarize yourself with the nature of the industry and some issues that are commonly faced by medical spa owners and operators. The specific rules and regulations that govern medical spas may be a bit difficult to pin down, but ignorance is never an acceptable excuse.

The industry

The American Medical Spa Association (AmSpa) defines a medical spa as follows:

“Medical spas operate under the full-time supervision of a licensed medical professional in a spa-like setting. When visiting a medical spa, patients can be pampered with traditional spa services but also have the option of getting medical services like Botox, laser hair removal and medical-grade skin therapies. The medical professionals of the med spa are licensed, educated and trained in the medical procedures and treatments provided to ensure the highest level of care for every patient. State regulations differ as to what type of ‘medical professional’ can be an owner or medical director of a medical spa, so we recommend you contact your local attorney for your state’s laws and regulations.”

The blanket term “medical spa” covers a range of establishments, including laser clinics, free-standing medical spas and Botox bars. In addition to traditional storefronts, these businesses are turning up in hotels, shopping malls and airports as more and more physicians seek to supplement their incomes by opening medical spas.  

Despite this growth, the industry’s rules and regulations are somewhat nebulous. However, there are a few core principles that conscientious medical spa owner and operators can observe to keep themselves out of legal trouble.

Medical spas are regulated as medical facilities
Laws governing the industry vary from state to state 

A medical spa can be a profitable business venture, but it can also attract legal problems that can stifle its earning power. Following are the top legal issues that medical spa owners and operators commonly encounter:

The Legend of the “Medical Aesthetician”

Aestheticians are the fastest-growing segment of the medical spa industry. In nearly every state, aestheticians are regulated as an individual profession. However, you should be wary of anyone who refers to herself as a “medical aesthetician.” Simply using the term is enough to trigger an investigation in many states.

Why? Because in most states, aestheticians cannot perform medical procedures, and suggesting otherwise is inherently misleading. The proper term is “aesthetician in a medical spa.” Check your spa’s business cards, website and marketing materials to make sure that the term “medical aesthetician” is nowhere to be found. You may be inviting far more scrutiny than you realize simply by using an improper title. Read more on misleading med spa titles here.

The Commission Conundrum

Offering employees commissions for bringing in business may seem like a great way to incentivize performance, but in most states, it is illegal. Why? Because in states that recognize the Corporate Practice of Medicine, all medical fees generated by a medical spa must be paid only to a physician or a physician-owned corporation. Splitting fees from medical procedures with a nonmedical employee is known as “fee-splitting,” and it is prohibited by law. If you are taking or giving a commission in a state that observes The Corporate Practice of Medicine Doctrine you are exposing both yourself and your medical spa to disciplinary action.

“If a medical spa is found to have done this, the physician faces suspension or revocation of his or her license, as well as a significant fine,” says Alex Thiersch, JD, founder and director of AmSpa. “The employee who receives the commission payment also faces a significant fine, so all involved should make sure that this is avoided. States are cracking down on fee-splitting, so there’s no better time than now to make sure your house is in order.”

Instead of offering commissions, medical spa owners and operators should enact a preset bonus structure to reward employees. That way, they can show their appreciation without putting themselves in regulatory crosshairs. There are two compensation packages available in the AmSpa store (among other business-building tools) that offer ways for you to incentivize your stay while staying within the bounds of the law.

Gift Cards

You may also wish to reward employees or even patients who bring in business with gift cards, but doing so in a medical setting such as a medical spa can represent a violation of state and federal anti-kickback laws, which prohibit physicians from paying for referrals. These laws are designed to ensure that physicians cannot simply buy patient referrals. 

“Because gift cards have a cash value attached to them, they can be viewed as representing a kickback and, therefore, expose the practice to legal action,” writes Thiersch

Supervision and delegation

Medical spa physicians are busy people. For example, in many states, a physician is required to conduct an in-person initial consultation and exam on every patient who intends to undergo a medical procedure, including laser treatments and injectables. Obviously, this would require physicians to spend a large amount of time conducting these exams and far less time performing more lucrative procedures. Luckily, this task can often be delegated to mid-level practitioners—nurse practitioners or physician assistants, for example—since it is within their scope of practice.

Generally, any patient care task at a medical spa can be delegated to whoever the physician wants, provided that person has been properly trained, is experienced and is properly supervised. For example, laser technicians can perform laser treatments, because those tasks fall within their scope of practice. Aestheticians, on the other hand, typically cannot perform medical procedures, so they cannot be delegated such tasks. Make sure that your medical spa complies with these standards. Read more about supervision and delegation here.

Ownership

In states that enforce the Corporate Practice of Medicine Doctrine, only licensed physicians or physician-owned corporations may own a medical corporation. By definition, medical spas are medical corporations and thus, in states that observe the corporate practice of medicine, only physicians are legally allowed to own medical spas. 

Although this is unfortunate for aestheticians who would like to try to cash in on this growing industry at an ownership level, there are other ways for aestheticians to get a piece of the pie. Aestheticians typically can own the management company that administrates the day-to-day operations—billing, purchasing supplies and equipment, leasing space, providing support services, etc.—of the medical spa. Such a company cannot share in the profits of the medical spa, but it can be paid a fee by the medical corporation. Read more about non-physician medical spa ownership structure here.

You can attempt to find more information about topics such as these and your specific situation by conducting Internet searches for terms such as “medical practice act,” “[your state] board of regulation” and “aesthetician act.” However, such information is difficult to find, and there is little of it available in many states. AmSpa members can check their state’s medical aesthetic legal summary or take advantage of their annual complimentary compliance consultation call with ByrdAdatto.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp for a deeper dive into medical spa legal topics, and to learn strategies to make your practice efficient and profitable.

Renee E. Coover, JD, is an associate with ByrdAdatto, a law firm focusing on business, healthcare, and aesthetics. She has a unique background, blending litigation with healthcare law. A former litigator in high-stakes employment cases, Renee has extensive experience with counseling and representing businesses in employment matters, policies, and contract disputes, and defending business owners in state and federal trials. She has also served as General Counsel for the American Med Spa Association, advising health care professionals on regulatory and legal issues governing the medical spa industry.

Tags:  Business and Financials  Med Spa Law  Med Spa Ownership 

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