Print Page | Contact Us | Sign In | Register
AmSpa Now
Blog Home All Blogs

Tennessee Law Aims to Make Medical Spas Transparent

Posted By Administration, 7 hours ago

By Alex Thiersch, Founder and Director of the American Med Spa Association (AmSpa)

Tennessee medical spas are, for the most part, governed by laws that are very similar to the laws that regulate such practices in other states. (AmSpa members can check their medical aesthetic legal summary to find the laws governing their practice.) However, as part of a bill that was passed in 2015, Tennessee has taken the extremely unusual added step of defining “medical spa”. 

The Definition

According to the law, which can be read here, a medical spa is “any entity, however named or organized, which offers or performs ‘cosmetic medical services.’” The law also requires all medical spas, and medical spa medical directors, to register with the state’s health professional boards. Lawmakers hope that this regulation will help practitioners in the Volunteer State become more transparent.

Registration

For example, if you are the medical director or supervising physician of a medical spa in Tennessee, you are required to fill out a form to register with the state. Likewise, if you are running a medical facility that offers cosmetic medical services primarily, you must register with the state of Tennessee.

Other requirements in the law lay out what must be disclosed in this registration, and in the practice’s advertising. For example, if the medical director is not board-certified as a plastic surgeon or a dermatologist, that fact must be divulged. This is a laudable step, as it ensures the public has a significant amount of information available to it. It tells consumers right up front that a practice is a medical spa, and it allows them to know, in no uncertain terms, which doctors are affiliated with the practice. Click here to read about general best practices to make sure your medical spa advertising is legally compliant.

Treatments

Aside from the registry, Tennessee’s regulations are fairly similar to those of other states, in that some are very specific and can be defined narrowly, while others are more vague and present some grey areas. Generally speaking, though, all treatments that are offered at a typical medical spa—light-emitting devices, laser treatments, Botox, etc.—are considered to be medical treatments. Click here to read more about medical vs non-medical treatments in med spas.

Delegation

Tennessee has a fairly broad, yet restrictive delegation statute, which appears to say that a physician is authorized to delegate treatments only to LPNs, RNs, NPs, PAs, and, oddly enough, pharmacists. However, this statute does not provide any direction when it comes to delegation to unlicensed individuals. Therefore, it must be assumed that in Tennessee, you must be a licensed practitioner to fire a laser, for example. This is unlike similar delegation statutes in other states, such as Texas and Illinois, which allow physicians to essentially delegate to whoever they want, provided that person is operating within his or her scope of practice. Click here to see AmSpa’s webinar on the basics of medical spa delegation, free to AmSpa Plus members.

Ownership

Tennessee does not allow anyone other than a physician to own a medical spa, although in some instances, PAs and NPs can own practices and can enter into contracts with physicians. If you are a PA or NP who wishes to look into medical spa ownership, you should reach out to ByrdAdatto to discuss how to structure it. A consultation is free to AmSpa members. Of course, an MSO is a possible solution that permits a certain amount of ownership to a non-physician, but as we don’t want anyone to be a test case, the prudent and conservative approach in Tennessee is to make sure a physician owns the facility.

See the Tennessee medical aesthetic legal summary for more information about laws governing medical spa practices in the Volunteer State.

We’ll be discussing these regulations and many others at our Medical Spa & Aesthetic Boot Camp at the Doubletree Nashville Downtown in Nashville on Oct. 14 and 15. Join us there to learn all about how to run a compliant, successful medical spa in Tennessee and throughout the country. Click here to learn more and register, and click here to see the full schedule of Boot Camp dates.

 

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

Share |
PermalinkComments (0)
 

Connecticut Allows Private Cause of Action for HIPAA Violations

Posted By Administration, Friday, September 14, 2018

Jay Reyero, JD, Partner, ByrdAdatto

As a medical facility, any med spa must be HIPAA compliant. While HIPAA does not contain a rule or regulation providing an individual a remedy for a breach nor are violations of HIPAA a specific cause of action, HIPAA is increasingly being accepted as the standard of care with respect to handling confidential patient information. 

In a recent Supreme Court decision, Connecticut joined the list of other states recognizing a private cause of action against health care providers for HIPAA violations.

In the case, a healthcare provider received a subpoena requesting production of all the medical records of one of its patient involved in a paternity suit. In response to the subpoena the healthcare provider mailed a copy of the medical records to the court. As a result, the other party of the paternity suit obtained access to the medical records and began harassing the patient. The patient sued on multiple negligence counts and breach of contract.

In its opinion, the Connecticut Supreme Court concluded that “a duty of confidentiality arises from the physician-patient relationship and that unauthorized disclosure of confidential information obtained in the course of that relationship gives rise to a cause of action sounding in tort against the health care provider, unless the disclosure is otherwise allowed by law.” To determine whether disclosure was allowed by law, the Supreme Court pointed to the requirements under HIPAA for responding to a subpoena because:

“to the extent it has become the common practice for Connecticut health care providers to follow the procedures required under HIPAA in rendering services to their patients, HIPAA and its implementing regulations may be utilized to inform the standard of care applicable to such claims arising from allegations of negligence in the disclosure of patients’ medical records pursuant to a subpoena.”

While most healthcare providers think of HIPAA as only an enforcement tool utilized by the Federal Government, this case further demonstrates the increasing use of HIPAA as the standard of care when it comes to common-law causes of action. Regardless of whether HIPAA is applicable to a particular healthcare provider, all healthcare providers need to be cognizant of its rules and regulations, as they may be held to such standards and rules. 

HIPAA isn’t the only standard that could come into play as typically there are other standards such as state law, licensing board rules, and ethical rules. Healthcare providers would be wise to reevaluate their policies and procedures and ensure they are in line with the applicable rules and standards to ensure the proper handling of confidential patient information within their organization. AmSpa members can check their state’s medical aesthetic legal summary to find the laws governing their practice.

For more information on patient privacy requirements in medical spas sign up for AmSpa’s live webinar on the topic, free to AmSpa members.

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

 

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

Physician Supervision: Keeping the “Medical” in Medical Spas

Posted By Administration, Thursday, September 13, 2018

By Renee E. Coover, JD, ByrdAdatto

Medical spa laws regarding physician supervision can be critical to a practice’s compliance plan, particularly if the practice utilizes nurse practitioners, physician assistants, nurse injectors, laser techs, or other non-physician providers to administer treatments.

Given the current economic landscape for medical practices, an increasing number of physicians are seeking alternative sources of revenue outside the traditional practice of medicine. Many physicians are turning to medical spas as an additional or alternative source of income, not wrought with the same Medicare/Medicaid and insurance issues currently plaguing the healthcare industry. But as physicians flock to medical spas in the hopes of making an easy income, many overlook the fact that a certain level of supervision is still required for all medical treatment. At the end of the day, the physician is responsible for every patient and if something goes awry, the physician’s license is on the line. 

Recently, our law firm has exploded with calls from physicians and med spa employees asking questions about physician supervision like: 

  • Does the doctor need to be present at all times? 
  • Does the doctor need to see every patient? 
  • What if the doctor consults with the patient over Skype- is that allowable? 

Of course, the answers to these questions, and many others, depend upon your particular state’s laws and regulations. AmSpa members can check their state’s medical aesthetic legal summary to find the answers to their med spa compliance questions.

The Practice of Medicine

First and foremost, it is crucial to know what med spa services require physician supervision in your particular state and what constitutes an adequate amount of supervision. In California, for example, all medical treatments – including Botox and laser hair removal – require physician supervision. Although a physician may delegate medical treatments and initial patient consults to nurse practitioners (NPs) and physician assistants (PAs), the physician must be involved and available to patients in the event of an emergency. 

Ultimately, the physician is responsible for each patient that walks through the door of a med spa. Some states have additional oversight requirements as well. In Illinois, a medical professional must be onsite at the med spa at all times when medical procedures are performed. This means that if a physician owner only has one other employee and that individual is a non-medical professional, the physician must be onsite at all times to supervise the medical procedures. 

Many physicians don’t realize, at least not right away, that treating patients in a med spa is just like any other practice. Most medical spa treatments by and large are still considered the practice of medicine, and the physician must assume ultimate responsibility for all of the patients that are seen and treated at the med spa. The physician must ensure that proper protocols are in place, oversee treatment plans, and safeguard patient confidentiality. While many of these tasks can be delegated, it is the physician, not the med spa owner or the employees, who is going to be held responsible if something goes wrong.

Experience and Training

One pitfall is the physicians’ notion that they can supervise medical tasks outside of their specialty practice, but in most states a physician in a med spa must specialize in, or at least have experience and training in, aesthetic medicine. In other words, the physician overseeing the medical spa and whose license is ultimately on the line, must actually practice aesthetic medicine.

Frequently, general practitioners, OB/GYN’s and emergency room physicians are quick to sign on as “medical directors” of med spas even though they have no experience or training in injectables, laser treatments, or any other aesthetic procedures, but this can get them in trouble fast. Even dermatologists and plastic surgeons should seek out training in these types of medical treatments in order to properly supervise the aesthetic treatments being offered at the med spa.

For more information on medical spa supervision and delegation requirements watch AmSpa’s medical spa webinar on the topic, presented by Michael Byrd, JD, partner at ByrdAdatto.

Telemedicine

With the advent of telemedicine, physicians frequently want to know if they can use real-time interactive communication on programs like Skype or Facetime to consult with and examine patients instead of meeting each new patient in-person, but this remains a gray area in the law. There is a fine line between giving generic health information over a smartphone and actually diagnosing or treating a patient.  Telemedicine is viewed as a cost-effective alternative to the more traditional face-to-face method of providing medical care and in some states it is being cautiously embraced. In Oklahoma, for instance, the state medical board recently passed telemedicine rules exempting physicians from face-to-face meetings with patients if certain criteria are met. Not every state is on board with this and only time will tell if telemedicine will be the future of medicine. Read more on telemedicine in medical spas here.

The bottom line is that physician supervision in the medical setting is a key component to running a successful and legally compliant med spa business. If you are unclear about the level of physician supervision required in your state, you should seek legal guidance from an experienced attorney immediately. AmSpa members can take advantage of their 20-30 minute annual compliance consultation with an attorney from ByrdAdatto.

For more ways to build and run your medical spa practice legally and profitably attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

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:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Employee Types  Med Spa Law 

Share |
PermalinkComments (0)
 

Social Media Advertising: Are You Legally Compliant?

Posted By Administration, Friday, September 7, 2018

By: Sam Pondrom, JD, Associate at ByrdAdatto

When it comes to advertising, social media is the hot new trend. It’s cheap, has a far reach and the potential to lure in many new customers. But it can also cost you if you aren’t advertising yourself and your business accurately. (AmSpa members can check their state legal summary, or utilize their annual compliance consultation with the business, healthcare, and aesthetic law firm of ByrdAdatto for more information on medical spa law.)

Social media marketing is being embraced across industries because of its cost-effective, direct-access marketing to potential consumers.  An additional bonus to social media marketing is its self-selecting nature, which allows social media users to seek out the advertising themselves, making them more receptive to the messages.  But when it comes to using social media marketing to select a plastic surgeon for treatment, it is important that social media users still perform their due diligence to ensure the advertisements are posted by board-certified, credentialed plastic surgeons.

A report recently published by the Aesthetic Surgery Journal examined all of the plastic surgery related advertisements posted to Instagram on a single day—January 9, 2017—to assess who was publishing the social media content.  The Journal found that there were about 1.79 million Instagram posts on that day that included at least one plastic surgery-related hashtag, like #plasticsurgery, #plasticsurgeon, #breastlift, #liposuction, or #brazilianbuttlift (hashtags categorize content and clicking on a hashtag retrieves similar content; they are functionally a search for similar content).  The Journal then evaluated the content of the top nine posts (top posts are those with the most engagement) in 21 plastic surgery related hashtags

The Journal also found that only 17.8% of the top posts for these hashtags came from board-certified plastic surgeons.  Another 26.4% came from physicians that did not have specialized plastic surgery training, and another 5.5% of the top posts came from persons who were not physicians at all, including dentists, medical spas with no physician/medical director, and even one hair salon.  The Journal also found that the majority of the posts were self-promotional (67.1%), rather than educational (32.9%), and that board-certified plastic surgeons were much more likely to post educational content than non-plastic surgeons (62.1% versus 38.1%, respectively).

This is particularly troubling because of social media’s reach and influence on young people, who now make up a large sector of the plastic surgery population in our country. The American Society of Plastic Surgeons reported that in 2014, nearly 64,000 cosmetic surgery patients were aged 13 – 19 and industry experts believe this number increases every year.  Moreover, in 2016, the American Academy of Facial Plastic and Reconstructive Surgery polled its members and more than half of the respondents reported an increase in cosmetic procedures in patients under age 30 in 2016. 42% of respondents also reported that their clients were at least partially motivated to seek plastic surgery because of a desire to look better in selfies posted to Instagram, Snapchat, and other social media platforms.

This means that social media users should research potential surgeons beyond their social media presence, and users wanting plastic surgery should seek out a board-certified plastic surgeon.  Board-certified plastic surgeons are doctors with more than six years of surgical training and experience, at least three of which are specifically in plastic surgery.  Moreover, social media users should move beyond Instagram and meet with the surgeon in person to obtain information like how many surgeries the surgeon has performed, what recover times are, and whether the patient is a good candidate for the surgery.

There are many resources to verify whether a physician is a board-certified plastic surgeon, including the American Board of Plastic Surgery’s website that lists physicians’ credentials, the American Society for Aesthetic Plastic Surgery that maintains a searchable database of board-certified physicians, and the America Society of Plastic Surgeons that allows a person to search for board-certified plastic surgeons by location.

To learn about legal and business best-practices to keep your med spa compliant and profitable, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps and be the next med spa success story.

For more medical spa legal and business tips sign up for our email newsletter to receive business strategies, news and med spa law directly in your inbox.

As the youngest of three brothers, Sam Pondrom learned early on how to work effectively as part of a team.  After graduating from Oklahoma State, an intrinsic sense of curiosity and a keen eye for details led Sam to work as an accountant for two Engineering-News Record top 40 construction firms.  It was here where he honed his ability to analyze complex issues and craft clear, concise answers.  Sam utilizes these skills to work in partnership with our clients to resolve their complex business and regulatory concerns in the most simple, straightforward way.

 

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

Share |
PermalinkComments (0)
 

Non-competes, Non-solicitations, and Medical Spa Employment Contracts

Posted By Administration, Thursday, September 6, 2018

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

Excellent medical spas require a commitment to building an excellent team, and once that team is in place many medical spa owners look to non-compete and non-solicitation clauses to protect their investment in time and training. Conscientious medical spa owners invest a great deal of time, effort and money toward making their employees the best they can be, and these contractual clauses, known as restrictive covenants, can prevent former employees from working for a competing medical spa and taking its clients and/or employees for a certain period of time. Implementing these clauses and enforcing them, however, are two very different things, so medical spa owners and operators must understand what they’re all about before attempting to utilize them.

Non-competition Agreements

A non-competition agreement is a part of a contract that is designed to bar an individual from working for a competing medical spa for a set period of time in a designated geographic area. If employees with non-competition clauses in their contracts choose to leave your medical spa, they would theoretically be subject to legal action if they went to work for another medical spa within the agreed-upon time span and geographic area.

This seems fairly straightforward; however, in reality, non-competition agreements are somewhat difficult to enforce to their fullest extent because American courts tend to be very reluctant to prevent people from working where they want. 

As with many things in this industry, the laws governing these arrangements vary from state to state. California, for example, has essentially established a ban on non-competition agreements. In Illinois, according to Renee Coover, JD, attorney with the law firm ByrdAdatto, “In a 2015 decision, the Third District of the Illinois Appellate Court readily followed and applied a rule established by a ground-breaking 2013 First District Appellate Court ruling. In Prairie Rheumatology Associates, S.C. v. Francis, the court reiterated that continued employment is sufficient consideration for a non-compete only where the employment is for a substantial period of time.  Citing the 2013 Fifield v. Premier Dealer Services, Inc. opinion, the court held that two or more years of continued employment amounts to adequate consideration. This means that the employee must be employed, under the terms of the non-compete agreement, for two years before the non-compete is enforceable against the employee.”

Non-solicitation Agreements

A non-solicitation agreement is a part of a contract that is designed to prevent a former employee from soliciting clients and/or other employees from your practice for a specified amount of time. In the medical spa setting, it’s not unusual for patients to become attached to the nurse practitioners, laser technicians and nurse injectors to whom physicians commonly delegate treatment. 

When one of these people decides to leave a practice, that practice needs to make sure that no effort is made to take said patients along—those are the practice’s patients, not the individual’s. If former employees make any effort to reach out to those patients and entice them to follow the employees to another practice, it is a clear violation of any non-solicitation agreement has been accepted.

Unlike non-competition agreements, non-solicitation agreements are commonly enforced, as courts are consistently willing to punish the misappropriation of a company’s assets—in this case, patients and employees. And with good cause—imagine the financial hit a medical spa could take if nurse injectors or laser techs were simply allowed to take the clients they’ve treated when they leave. However, like with non-compete agreements, you must be sure that any non-solicitation agreement you employ is carefully crafted to best protect your interests. 

Keys to Enforceable Contracts

Simply writing a non-competition or non-solicitation agreement into your employment contracts does not guarantee that they will be enforced when push comes to shove. But if these clauses adhere to the following guidelines, a medical spa’s chances of collecting damages if they are violated improve dramatically.

Adequate Consideration: In order to get something—in this case, protection for your medical spa should an employee leave—you must give something. This is known as adequate consideration, and every contract must include it in order for it to be enforceable. If you include a non-competition or non-solicitation clause in employees’ initial contract when they are hired, it is understood that employment is the consideration they are receiving in return for signing the contract.

“In the employment context, when an employee is at will, meaning he or she can be terminated at any time without cause, the employment itself constitutes adequate consideration,” says Coover. “Similarly, if a new employee signs a non-compete agreement as a condition of employment, the employment itself is also adequate consideration.”

However, if you wish to incorporate one of these restrictive covenants into an existing contract, some states require that you provide your employee with something extra in return for it—typically a pay raise or a promotion These states do not consider continued employment to be adequate consideration. If an employee does not receive something in return for this newly incorporated restriction, it is unlikely that a court will view the contract as enforceable. 

Coover adds, “For continued employment to be adequate to enforce a non-compete agreement on the existing employee, the employment must last a sufficient amount of time. For example, if a new employee signs a non-compete and the employer fires the individual the next day, it would not be fair to restrict the employee from competing for years in the future.”

Legitimate business interests: Courts typically permit the enforcement of restrictive covenants when they are utilized in the protection of confidential information, investment in specialized training and patient/client relationships. Make sure that any restrictive clause you wish to employ addresses these issues in some fashion—reach for anything more and you risk its enforceability.

Reasonableness: A restrictive covenant should not be excessively long in duration or cover a geographic area any larger than need be. Of course, both of these factors are case-specific—if a medical spa is in an urban area with a great deal of nearby competition, for example, it makes sense that the geographic restriction should cover a smaller area than if it were in a small rural community with one other medical spa in a 20-mile radius.

AmSpa members can utilize their annual complimentary compliance consultation with ByrdAdatto for any further questions regarding restrictive covenants in employment contracts.

A Crucial Decision

When delving into the world of restrictive covenants, it’s crucial to make sure that any non-competition or non-solicitation contract provided to employees be legal and binding. After all, a medical spa’s employees and clients are its lifeblood, and need to be protected. If you have existing contracts, make it a point to have a local health care attorney review them for viability. If you don’t have them in place and want to include them in your employment packet, make sure to work with a health care attorney to craft them correctly the first time.

To learn more legal and business best-practices attend a Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

Subscribe to AmSpa’s email newsletter for medical spa news and legal and business tips delivered directly to your inbox.

 

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

Share |
PermalinkComments (0)
 

HIPAA Breaches: How to Protect Patient Privacy in Your Med Spa

Posted By Administration, Friday, August 31, 2018

By Jay Reyero, JD, Partner, ByrdAdatto

Patient privacy and HIPAA go hand-in-hand in any medical setting, including your med spa. While cyberattacks, whether on large hospital systems or small clinics, make for splashy headlines, healthcare providers should not forget to look within when it comes to vulnerabilities.

A recent examination by Verizon of security incidents across 27 countries found that the majority (58%) of healthcare protected health information (“PHI”) data breaches were due to insider threats. (For more information on patient privacy, sign up for our upcoming live webinar. It is free for all AmSpa members.)

The report highlighted several areas that healthcare providers encounter on a frequent basis where risks could arise internally, such as the potential for privilege abuse. Personnel require access to specific PHI to perform their duties but providing such access puts them in position to easily use or access the PHI for other, malicious purposes. This can be especially problematic with disgruntled or recently fired employees. The three steps a healthcare provider should take to protect itself are: (1) Identify; (2) Address; and (3) Audit.

Identification requires healthcare providers to identify all of the vulnerabilities to PHI; not only those risks from the outside, but just as important, those risks from within the organization. 

Once a healthcare provider identifies its vulnerabilities, steps should be taken to address each by implementing the appropriate safeguards necessary to protect the PHI, both in terms of technology and internal policies and procedures. Many may recognize this as the first step of any HIPAA compliance plan, which is the Risk Analysis and Management required under the Security Rule. 

Finally, healthcare providers must continue to be vigilant against the ever-present threat to extremely valuable data through regular audits of the systems and policies in place to find new vulnerabilities or current vulnerabilities being exploited.

Healthcare providers would be wise to conduct an updated (or first) risk analysis and understand where they stand in the fight against threats to PHI.

For more information on ways to build and run a successful, profitable, and legally compliant medical spa attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps and be the next med spa success story.

ByrdAdatto represents physician practices, dental practices, law firms, medical spas, and other professional services companies throughout the United States. AmSpa members can take advantage of an annual compliance consultation call with the firm.

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

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

Share |
PermalinkComments (0)
 

The Basics of Understanding Medical Aesthetic Laser Laws

Posted By Administration, Friday, August 24, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Laser laws in the medical spa industry aren’t always easy to find or understand, especially since they vary from state to state. Laser and radiofrequency devices have become profit leaders in many aesthetic practices due to results that some of these devices are able to deliver. However, with great technology comes greater regulation, as federal and state governments seek to protect the public from potential harm from misuse of this technology.

On the federal level, the Food and Drug Administration regulates medical lasers, as it does with other medical devices.  [Click here for information on the FDA’s recent warning regarding energy-based vaginal rejuvenation devices.)

On the state level, a variety of regulations have been adopted, and the spectrum of regulations is massive. These rules can be confusing, as they can restrict everything from who can own the machine, to who can develop the treatment plan, to finally, who can actually fire the laser. 

To make matters more confusing, some states have few, if any, laws directly addressing lasers. Instead these states have general laws on medical procedures or devices that indirectly control laser usage, and the laws are enforced by the medical boards.

As an example, Texas laws divide medical lasers into two categories.  One category includes laser radiation and intense pulsed light devices. The other category covers laser or pulsed light hair removal devices. Each class is restricted as to who can own the lasers, where they can be used, who can use them, and what special or additional licenses or registrations are needed.

In Texas, intense pulsed light (“IPL”) devices can only be used in a medical clinic and under the supervision of a licensed medical doctor. The device must be registered with the Texas Department of State Health Services. Further, there are substantial restrictions as to who can perform the IPL services under the doctor’s supervision. Light-based hair removal devices in a medical practice are not required to be registered with the state, as the procedure doesn’t remove part of the epidermis. Further confusing the matter, a non-physician can get a Texas license to open a laser facility. But this license limits the light-based device types and their uses at the facility, and enacts additional supervision requirements.

Compare this to laser laws in Georgia, or California, and you can begin to see how requirements can vary drastically.

AmSpa members can check their medical aesthetic legal summary to see laser laws in their state. 

The use of lasers in the aesthetic industry does not appear to be slowing down. Having a clear understanding of your state’s laser licensing and regulatory scheme is essential to avoiding legal pitfalls in your practice. For more information and guidance on your state’s laser regulation and oversight requirements please contact the law firm of ByrdAdatto

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 

Share |
PermalinkComments (0)
 

Subscriptions: The Next Level of Membership Programs

Posted By Administration, Friday, August 17, 2018

By Michael S. Byrd, JD, Partner at the law firm of ByrdAdatto

Med spa patient loyalty and retention is one of the biggest concerns among med spa owners, according to the 2017 Medical Spa State of the Industry Report. The report also states that fully 55% of medical spa practices have instituted some sort of membership program. Paid membership programs can be a valuable tool to increase customer retention as long as you are keeping up your standard of care, and these programs can also be a huge help in gathering operating capital up-front and projecting future income.

“This membership model built Skin Body Soul,” says Brandon Robinson, founder of Skin Body Soul Spa. Robinson believes that paid memberships help to bring in patients that are willing to commit to the spa as much as the spa is committed to the patients.

Subscription billing for products flips the traditional product purchase model on its head. Rather than purchase a product, consumers purchase the right to use the product. Netflix and Spotify embody the power of this business model.

On January 17, 2016, Forbes magazine published an article titled  How the Subscription Economy is Disrupting the Traditional Business Model. Tien Tzuo, CEO of Zuora, points out that in this model the emphasis must be on the consumer experience and relationship.  Tzuo states, “Remember that subscriptions are relationships, and relationships are a two-way street!”

With the success of the subscription billing model for products, the question becomes whether this model can work with professional services. The aesthetic industry has seen a shift toward providing non-invasive services on a subscription basis. HintMD, a technology startup based in Silicon Valley, developed a dynamic subscription platform to enable medical aesthetic professionals to offer their services via a subscription offering. 

Aubrey Rankin, CEO of HintMD, says, “Our aesthetic subscription platform not only enables consumers to gain access to high-end aesthetic services and providers, but more importantly makes it easier for patients to commit to their prescribed treatment plan. By a patient simply following their treatment plan, a true win-win situation is created. Patients achieve optimal treatment outcomes through the ease of a predictable monthly subscription payment, and the aesthetic practice sees an increase in patient loyalty, which ultimately drives growing practice revenues.”

Our law firm, ByrdAdatto, has offered legal services on a subscription billing model for several years to our larger clients, and in January 2017, our firm expanded the subscription billing model to provide access to our smaller business clients as well. The adoption of this subscription business model by our clients far surpassed our expectations.

The goal with ours was to provide options for our clients in choosing how to pay for legal services. A little over a year since the roll-out, our Access+ subscription billing platform now represents close to 50% of our monthly revenues.

For organizations considering a transition to a subscription billing model, the following must be considered:

  • The subscription billing model does not replace the need to provide excellent services; rather, it emphasizes the need to deepen the relationship with clients.
  • Defining the scope of covered services becomes imperative.
  • Key performance indicators to measure the success of your business dramatically change.
  • Plan your cash management in the transition process.

Subscription billing is not for everyone, so proceed with caution before completely switching to this billing platform.

If you believe you are ready to switch, but are looking for somewhere to start check out Ten Steps to Developing & Launching Medi Spa Memberships in the AmSpa Store.

ByrdAdatto represents physician practices, dental practices, law firms, medical spas, and other professional services companies throughout the United States. AmSpa members can take advantage of an annual compliance consultation call with the firm.

If you have any questions regarding your business model, need assistance with designing corporate structure, or merger and acquisition activity, feel free to reach out to us at mgire@byrdadatto.com or call 773-831-4692.

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:  AmSpa's 2017 Med Spa Statistical Survey  Business and Financials  Med Spa Law  Med Spa Trends 

Share |
PermalinkComments (0)
 

Keep Calm and Carry On: A Quick Word on the FDA’s Warning on Vaginal Rejuvenation Devices

Posted By Administration, Thursday, August 16, 2018

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

The recent warning by the U.S. Food and Drug Administration (FDA) to manufacturers of vaginal rejuvenation devices has caused quite a stir. And for some, the reaction has been closer to an all-out panic. Already, I’m hearing from concerned members threatening lawsuits, trying to return their devices, and demanding immediate refunds from manufacturers. 
 
Believe me, I understand. Had I purchased a device for several hundreds of thousands dollars, I would be alarmed by the warning, too. But as with many things in this industry, the reaction to the FDA warning may end up being more damaging than the warning itself. The ensuing panic and reaction could end up threatening a procedure that, by all accounts, is very safe, very effective, and enjoys unprecedented patient satisfaction. 
 
So, I’m here to reassure everyone and, hopefully, calm the waters a little bit. DONT PANIC! Keep calm and carry on as normal. This is not the end of the world, and I doubt very much that any medical spa or provider has anything to worry about, including those who continue to offer these procedures.
 
The bottom line is this: vaginal rejuvenation is 100% legal for medical spas, and any physician can recommend and delegate the procedure using any of the devices at issue. This is called “off label” use of a medical device—using a medical device for a procedure other than what it is approved for by the FDA. This is done ALL the time. Botox, for instance, is not FDA approved for many, if not most, of the treatments it is used for. Indeed, most medical spas, surgeons and cosmetic derms are offering Botox injections off-label every single day. So long as the physician determines that, in his or her medical judgment, the treatment is appropriate and safe, these procedures can and should continue. There is no danger for medical spas here. The FDA doesn’t even have jurisdiction over medical spas or providers, so even if it wanted to do something (which it doesn’t), it couldn’t. There truly is no need to panic.

As AmSpa and the law firm of ByrdAdatto indicated in our joint statement on the matter:

“The FDA does not have any control over a physician’s ability to prescribe “off-label” which in this case would be when physicians are using the energy-based devices to perform vaginal rejuvenation procedures… What is important for med spas and other health care professionals to understand is that such “off-label use” is subject to the oversight of their medical boards.“ 

AmSpa members with additional questions about the warning can take advantage of their annual compliance consultation call with ByrdAdatto.

There are some things that all medical spas and providers should do, however. This warning is much more about marketing and advertising than it is about the actual treatment. All the FDA is saying is that manufacturers need to ensure that they are not marketing these machines for anything other than that which they are formally approved for. That’s it, nothing else. The FDA wants to ensure that the public, including medical spas, is aware that they have not approved these devices for things like tightening, dryness, or incontinence. That doesn’t mean you can’t use them for those conditions; it only means that the manufacturer cannot market their devices for those conditions.
 
I don’t recommend that anyone try to return their devices. What you should do is:

  1. Make sure that your consent forms are up to date and explain that the procedure is not FDA approved for vaginal rejuvenation; and
  2. Keep a close eye on your marketing material so that you are clearly explaining what you are offering is an “off label” treatment. Just be honest with your patients. Education is key. Like with Botox, medical professionals who are within their state’s legal scope of practice to perform these procedures are still OK to do so. Thus far, this practice has proved to be quite safe. 

In some ways, I wish the FDA had taken a less alarming approach to this issue, but, at the same time, I understand their position. Their job is to protect the public, and the manufacturers of vaginal rejuvenation devices are responsible for marketing their products legally. But this, like most things in this industry, will work itself out. There will be a device approved by the FDA for these conditions in the near future. Until then, do as the Brits do: Keep Calm and Carry On

I highly recommend that you listen below to the recent podcast we hosted with attorney Jay Reyero of ByrdAdatto Law Firm as he gives some great perspective—and advice—on this issue. Also, stay tuned for more as we’ve reached out to the FDA and are trying to get them on a podcast as well. Remember: AmSpa is here for you!

 
Subscribe on iTunes to be the first to hear new episodes. 

Tags:  Med Spa Law  Medical Spa Insider Podcast 

Share |
PermalinkComments (0)
 

Are Botox Parties Legal? Are They Worth It?

Posted By Administration, Tuesday, August 14, 2018

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

Botox parties are a common topic in med spa law because of how lucrative they can be, but are they legal?

One thing I love about the med spa industry is that med spa owners and providers are continuing to innovate. The ideas that come from AmSpa members on marketing, branding, and business always leave me impressed. This is one reason why it is so difficult to keep track of what’s legal and what’s not - many of the ideas we are asked about are brand new. They’ve never been tested before, and therefore it’s difficult, if not impossible, to determine where the legal constraints are.

While not new, Botox parties are an innovation like this. These are events hosted by a med spa or a provider, either at the med spa or another location, where people get together to socialize, learn about treatments, and try new treatments. Often the med spa provides discounts on product so that they can get new patients in the door. Often alcohol is served. These are highly social events that mix pleasure with aesthetics, which makes the idea of getting injected with a needle a little more palatable.

A question I get all the time, though, is whether these events are legal, particularly when they are held outside of the med spa (at someone’s house or a salon). And the question that always follows - is it worth it?

The answer to both of these questions is yes - it is absolutely legal (in most states - sorry, Nevada*), and it is ABSOLUTELY worth it. But like most things in this industry, both of these answers are dependent upon you adhering strictly to the law. No amount of money is worth losing your license, and, yes, I have seen nurses lose their licenses because of improperly hosted Botox parties. AmSpa members can check their medical aesthetic legal summary to find the law regarding Botox parties in their particular state.

The primary point to remember is that when you provide any medical treatment off site all the same rules apply. New patients must be seen by a doctor, nurse practitioner (NP), or physician assistant (PA) prior to being treated. Proper records must be kept. Consents must be signed. Before and After photos should be taken. Everything that you are required to do legally in your med spa should be done at the Botox party.

Additionally, check with your insurance carrier before the party to ensure that you have coverage for offsite treatments, and double check local ordinances regarding serving alcohol - sometimes a permit is required.

Initial Exam

The biggest risk at Botox parties, or any social event involving med spa treatments, is that a patient will be treated by an RN without first seeing the doctor (or NP/PA). All patients must be seen first so that a plan can be set. This can ONLY be done by an MD, or by an NP or PA operating under proper authority. Indeed, even if the patient consents to being treated by the RN without first seeing the doctor, that does not allow the RN to inject the patient without the patient first seeing a doctor.

At Botox parties this can be difficult because there are new patients socializing, there is sometimes alcohol being consumed, and everyone is more relaxed. This is a step that MUST be followed, though, because an RN cannot practice medicine, and therefore the RN cannot legally perform the initial assessment, establish the physician-patient relationship, and set a treatment plan. There are no exceptions to this rule.

Patient Consent

Equally as important is obtaining patient consents, including privacy waivers given that treatments are usually performed out in the open. And providers should be mindful of patients consuming alcohol. While not strictly illegal, we all know that alcohol makes people less inhibited and often clouds judgment. This is NOT good when it comes to patient consent. All patients should offer consent before they begin drinking, and the drinking should be kept to a minimum. This is not always easy, but trust me, if there’s an adverse outcome you’ll wish that alcohol was not involved.

Patient Privacy

Also be mindful of photos and social media. These events are a great way to market your med spa - people are having fun, everyone is happy, and you remove much of the clinical aspects of aesthetic medicine. Be careful, however, when photos or videos are posted - every patient is entitled to privacy, and if any patient has failed to sign a privacy release and an authorization to use their photos, there is a risk of a breach of patient privacy.

Are They Worth It?

So the fact that these events are legal begs the question - is it worth it? The answer is emphatically yes, provided you strictly adhere to legal guidelines. Botox parties and social events are a great way to get new clients introduced to your practice, pre-book treatments, and bring in some cash. To get started setting up your own events check out the Secrets to Successful Event Planning in the AmSpa Store.

The usual protocol is to offer discounts on treatments and pre-bookings (both for injectables and laser packages), provided they are purchased that night. Patients are encouraged to bring friends and colleagues to meet the providers and learn more about aesthetics. Depending on the size of the event, it is not uncommon for a practice to bring in six figures worth of treatments and bookings - in one day.

Even that kind of money isn’t worth losing your license, though, so be careful and diligent with your compliance efforts.

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

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

*Nevada recently passed a law restricting the injection of Botox and fillers to a doctor’s office, essentially banning the ability to host Botox parties.

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

Share |
PermalinkComments (0)
 
Page 1 of 5
1  |  2  |  3  |  4  |  5
Contact Us

224 N Desplaines, Ste. 600S
 Chicago, IL 60661

Phone: 312-981-0993

Fax: 888-827-8860

Mission

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

Follow Us: