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What the FDA Warning on Vaginal Rejuvenation Devices Means to You

Posted By Administration, 10 hours ago

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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Finding and Training Quality Staff the Top Concern of Medical Spa Owners

Posted By Administration, Tuesday, October 16, 2018

In 2017, AmSpa conducted a survey that asked medical spa owners to identify their top concerns in the industry. What we found was that, while compliance and larger business trends definitely weigh heavily on these people’s minds, finding and retaining talented, gifted employees is their primary concern. Following is a look at the top six areas of interest, according to the survey respondents.  

1. Finding, training, and retaining quality staff.
People truly are the most important part of any medical spa. The medical aesthetic industry is an experience-based business, so it’s no surprise that finding, training, and retaining quality staff is the top concern of medical spa owners. They’re looking for people who are not only qualified to perform neurotoxin injections, for example, but are also gifted salespeople who have the ability to promote the medical spa’s brand, since the industry is a unique confluence of medicine and retail. 

2. Staying compliant with regulations.
Obviously, compliance should be at or near the top of any list of medical spa concerns, since the rules and regulations that govern the industry are so ephemeral. Owners who want to remain compliant are good for the industry, since it suggests that, by and large, folks working in medical aesthetics want to do the right thing and run a tight ship, but may not know exactly how to do that. 

3. Growth
A medical spa owner who is concerned with growth is likely to be making money already, so seeing this listed so high suggests that these people are already doing quite well and want to find out how to do even better. 

4. Marketing and advertising
Because medical spas are medical facilities, marketing and advertising are quite a bit more complicated than they would be for a traditional medical practice or a retail outlet. Getting the word out about your medical spa can seem like a difficult balancing act and, again, the level of concern expressed by owners suggests that they want to do this the right way, but don’t quite know how.

5. Market saturation and competition
This is another sign of a healthy industry, although it certainly doesn’t seem like a good thing to people who have built successful businesses and then suddenly have to deal with newcomers who have seen how lucrative the industry can be. Learning how to provide the products and services your market wants is one of the keys to maintaining a successful medical spa.

6. Controlling costs and taking on debt
They say you have to spend money to make money, but how much is too much in the medical aesthetic industry? Keeping track of a medical spa’s finances, both in terms of everyday expenditures and big-picture financing, is vital for practice owners to understand, and its position on this list reflects that.

All of these concerns point toward the fact that this is an industry that is absolutely exploding. It’s difficult to find employees, because there aren’t enough qualified professionals; compliance is difficult because of quick expansion; competition is springing up all over the place—all these things point toward a robust industry, and these medical spa owners want to get their piece of the pie. We at AmSpa want to help you do just that, so stay tuned to learn more about all these factors in medical spa success.

Tags:  Business and Financials  Med Spa Ownership 

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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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How Core Doctors Are Missing Out With Med Spas, and How They Can Fix It

Posted By Administration, Thursday, October 4, 2018

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

The medical spa industry is worth over $4 billion and as it continues to boom core doctors—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and cosmetic dermatologists—are uniquely placed to do exceptionally well in this still-expanding space. As physicians, they are allowed to own medical spas, and ideally, they would not only profit from the medical spas themselves, but also use them to direct business to their surgical practices. After all, medical spas tend to do a lot of the same things these core doctors do, albeit non-invasively, and it does stand to reason that if patients go to a medical spa looking for a Botox injection, they might eventually want a nose job or a face-lift. In that case, the core doctor who owns the medical spa might be uniquely positioned to offer his or her services.

However, despite the apparent synergy between these two types of businesses, many of the core doctors who treat medical spas as extensions of their surgical practices end up very disappointed in the actual results. I chat with core doctors all the time, and those who have opened medical spas with the idea of using them primarily as feeders for their practices tend to view them as poor investments. Their medical spas tend to flounder, and the amount of business they drive to their surgical practices is disappointing.

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

A Different Kind of Practice

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

Medical spas are very different. Granted, they must follow the same rules and regulations to which more traditional medical facilities adhere, but the medical aesthetic field is unique in the medical world in that it is entirely elective and entirely cash-based. People who use medical spas do so because they want to, not because they need to, and treatments at medical spas are much less expensive than the ones available from core doctors’ surgical practices. Therefore, for a medical spa to succeed, it must have a high volume of patients, its employees must master the art of selling, and it must do what it can to get patients to return. In other words, it must be run like a retail center rather than a medical office.

For that reason, medical spa operators need to incorporate a totally different mind-set than the type that is typically utilized by core doctors. Medical spas run by core doctors who do not adapt to a more retail-oriented focus often end up failing. When I tell core doctors that I have medical spa clients who generate up to $6 million annually, they are usually blown away. Many of them cannot wrap their minds around how that can be possible.

Understand What You Know, And What You Don’t

In order for a medical spa to succeed in creating business for a core doctor’s surgical practice, it must first succeed on its own terms and, to facilitate that, core doctors typically need to let someone else run the show. Core doctors need to come to terms with the fact that the medical spa business is much, much different than the one they are used to, and they need to partner with people who are experienced with marketing and sales in a retail environment.

A core doctor’s time is better spent doing the things medical spas cannot do: highly profitable surgical procedures. If a core doctor can get a true businessperson to operate the med spa, they will do much better in the end. Giving up this control can be difficult for core doctors to do, since a lifetime of academic and financial success tends to make them think they can achieve anything. However, most doctors don’t go to business school—they usually don’t know retail and they don’t typically understand sales. These qualities—not medical knowledge or surgical skill—are what tend to make medical spas successful.

In addition, medical spa team members need to have the tools and the processes to be able to sell. A medical spa receptionist, for example, should not be someone fresh out of high school and being paid $12 an hour; a receptionist should be one of the highest-paid people on an administrative staff, because he or she needs to be able to sell. 

A medical spa should have talk tracks for nurses and estheticians, so they understand that their jobs are about selling themselves and selling the doctor. Employees at medical spas also need to understand that selling retail products is very important to maintaining a healthy business. These are things that successful medical spas do that may seem distasteful to doctors, who are used to a professional environment that is less aggressive. But this is the reality of the medical spa industry, and every day more and more physicians are finding this to be true.

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

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

Still the Practice of Medicine

Although a medical aesthetic practice must be focused on sales, it is also required to follow the medical rules and regulations of the state in which it is located. These laws can vary widely depending on your state, so consult an attorney familiar with aesthetics when setting up your practice and your procedures. AmSpa members can check their state’s medical aesthetic legal summary to see the rules and regulations governing their practice.

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

This can present difficulties for a core doctor who wishes to partner with a businessperson to run a medical spa, because it is likely that said businessperson is going to want some equity in the practice. If the state in which the medical spa is located observes the corporate practice of medicine, this would be illegal.

Ownership Options

There are options, however. If a core doctor wishes to partner with an entrepreneur to open a medical spa in a corporate-practice-of-medicine state, they can look into setting up a management services organization (MSO). As its name suggests, an MSO provides management services. It partners with a doctor, for whom a separate company is created; this doctor’s company exclusively provides medical services. 

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

Essentially, this is a lessor/lessee situation. More often than not, the MSO owns and maintains the facility, while the doctor occupies the space. The doctor pays the MSO “rent” for the right to occupy the space, and the MSO functions in much the same way as a landlord, maintaining the facility and keeping the doctor as comfortable as possible. 

However, unlike a rental agreement that is governed by a lease that dictates the occupant pay a set amount of money for a certain term, the amount paid to the MSO fluctuates according to the amount of business conducted by the physician. If the medical organization treats more patients in a month or quarter (depending on the terms of the agreement) than it did the previous month, the MSO will also make more money. This represents the sort of equity a core doctor’s business partner might seek—in function, if not form. Read more on MSOs here.

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

This is somewhat common at medical spas—the people who own and operate these establishments generally only wish to reward the people who bring business to the practice. But the fact remains that if a medical spa is found to be engaging in fee-splitting in a state in which it is illegal, the doctor who owns the practice could face the suspension or revocation of his or her license, as well as a significant fine. What’s more, the person who receives the commission payment is also subject to a fine. Again, a performance-based bonus structure can be offered as an alternative to commission. Read more about med spa compensation here.

Medical spa owners and operators who are not familiar with the ownership requirements in their states should contact an experienced health care attorney to learn what is expected of them. 

Becoming a medical director for a medical spa, rather than opening his or her own facility, is another option for a core doctor. A lot of core doctors I have represented are doing this very successfully. The advantage of this arrangement is that the core doctors don’t need to deal with actual day-to-day operation of a retail store; they can simply lend their name to a medical spa, perform some consultations, oversee the practice’s other medical professionals, and then high-tail it back to their own practice rather than needing to worry about the minutiae of the business. This can provide a core doctor with a look at the industry without requiring him or her to make the enormous ownership commitment. It’s important, however, to understand the risks and responsibilities of med spa medical directors before making this decision.

Conclusion

The core doctors who oversee a properly maintained and operated medical spa stand to gain a great deal from the arrangement. A successful medical spa can earn a lot of money by itself and, if a medical spa has a lot of patients, it makes sense that the number of referrals to an affiliated core doctor’s surgical practice would be higher than if the medical spa is struggling.

If a core doctor wants to enter the medical aesthetic industry, he or she cannot engage in half-measures. A medical spa that is created to function primarily as an addition to a surgical practice is unlikely to find a great deal of success; a medical spa that is designed to succeed on its own terms, however, offers numerous benefits to its owners, not the least of which is the possibility of increased surgical business.

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

 

Tags:  Business and Financials  Med Spa Ownership 

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