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New York Nursing Board Says Microneedling Is the Practice of Acupuncture

Posted By Administration, Wednesday, September 18, 2019

microneedling

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

Over the last several years, microneedling has exploded in popularity, becoming a core procedure in medical spas. According to AmSpa’s 2019 Medical Spa State of the Industry Report, 84% of medical spas offer some form of microneedling. The majority of states consider microneedling that pierces the outer layer of skin—the stratum corneum—a medical procedure that must be performed by an appropriately trained person under the supervision of a physician or other independent licensed health care professional. But New York has taken the unusual position that microneedling is part of the practice of acupuncture.

The New York Board of Nursing has provided guidance that microneedling is not within the nursing scope of practice; however, the Board of Acupuncture confirmed that microneedling is within its license’s scope of practice. It is not unusual for a procedure to be within the scope of some nurse licenses but out of others based on the skill and training needed for the treatment, but it is unusual is that all levels of nurses are excluded from performing microneedling, regardless of training. Otherwise, nurses in New York are able to perform a broad range of services in a medical spa. For example, when registered nurses are acting under the authority of a valid provider, they may inject neuromodulators and fillers, fire both ablative and non-ablative lasers, use radio frequency devices, and provide skin peels and light treatments. However, they may not provide miconeedling unless they are separately licensed in acupuncture.

This is a somewhat unusual interpretation, as although the two techniques both employ needles to pierce the skin, their goals and methodology are entirely different. New York defines the “profession of acupuncture” to entail the insertion of needles or application of heat, pressure or electrical stimulation on a point of the body on the basis of the theory of physiological interrelationship of body organs with a point or points of the body. On the other hand, microneedling typically is the insertion of needles into the skin for the purpose of stimulating collagen production. While certain types of microneedling may use energy or injections to improve the procedure’s effect on the skin, its goal is only to improve the skin tissue to which the treatment is applied, while acupuncture is meant to improve or affect a different organ or portion of the body than the area treated. And while this interpretation is unusual, it is not unique. The Massachusetts Board of Registration in Nursing, in an advisory ruling, has similarly interpreted microneedling to be outside the scope of nursing; an acupuncturist license is required to perform the procedure in that state as well.

I do want to stress that this information all comes from informal correspondence with the nursing and acupuncture boards. There currently is no law, rule or official advisory opinion stating that nurses cannot perform microneedling and acupuncturists can, so carefully review your own practice situation before making any major changes. We will continue to attempt to get some clear guidance on this unusual interpretation. AmSpa members can check their state legal summary, or utilize their annual compliance consultation with the business, health care and aesthetic law firm of ByrdAdatto for more information on medical spa law.

If you live in New York and want more information on this and many other topics relevant to your medical spa, attend AmSpa’s New York Medical Spa & Aesthetic Boot Camp October 12 – 13 at The New Yorker Hotel (A Wyndham Hotel) in New York City. Click here to register today and become the next medical spa success story.

Tags:  AmSpa's 2019 Medical Spa Statistical Survey  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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Is HIPAA the Patient Privacy Standard of Care?

Posted By Administration, Monday, September 16, 2019

patient record

By Courtney P. Cowan, JD, ByrdAdatto

Anyone working in the health care industry is intimately familiar with the Health Insurance Portability and Accountability Act of 1996, better known as HIPAA. Generally, the purpose of HIPAA is to establish minimum federal standards for protecting the privacy of protected health information (PHI). While it is widely understood that health plans, health care clearinghouses, and health care providers are potentially subject to HIPAA regulation at the federal level for maintaining patient privacy, what may be less well known is how the patient privacy standard of care established under HIPAA applies to a private right of action.

Only the U.S. Department of Health and Human Services Office for Civil Rights (HHS) and the state attorneys general can enforce HIPAA violations. As a result, HIPAA lacks a private right of action. This means that an individual whose PHI has been used or disclosed by a health care provider in violation of HIPAA may not bring a civil claim against the provider under HIPAA. HIPAA also preempts state privacy laws that are contrary to HIPAA, the exception being when a state law is “more stringent” than HIPAA regarding privacy protection.

With data breaches becoming increasingly common, individuals have attempted to circumvent HIPAA’s lack of individual enforcement power by bringing negligence claims under state law based on violations of HIPAA. Using HIPAA as the patient privacy standard of care in negligence cases is beginning to look more like the equivalent of a private right of action under HIPAA, which HIPAA does not allow. This essentially means that a violation of the HIPAA rules may be used to establish that a health care provider has breached the duty of care owed to a patient under state law negligence claims relating to the improper disclosure of patient PHI. As a result, health care providers should understand that a HIPAA violation may result in a variety of state law claims.

Perhaps even more alarming than the attempted private right of action as a HIPAA workaround is the recent trend of state courts both finding in favor of the plaintiffs bringing the private rights of action, as well as finding that HIPAA violation claims can be brought at the state level. In California, for example, a medical center found itself at the center of a major data attack, with 4.5 million patients affected by the breach. After suspecting suspicious activity on its network, it contacted the FBI for help. Although it took close to nine months to notify the patients of the breach, HHS ultimately found that the medical center followed appropriate protocol and was satisfied with the health system’s post-breach efforts to improve security. However, despite the findings by HHS, a California state court found that the medical center failed to notify its patients of a data breach in a timely manner and awarded a settlement of $7.5 million in favor of patients who had filed the class-action suit.

The Arizona Court of Appeals also added itself to a number of courts across several states holding that HIPAA may define the standard of care for state law claims. The claim before the Arizona court alleged a privacy violation by a Costco pharmacist when the pharmacist verbally joked about a man’s erectile dysfunction medication to the man’s ex-wife. The long and short of it is, the Arizona Court of Appeals ruled that negligence claims using HIPAA as the patient privacy standard of care could be brought against Costco in Arizona courts.

While data breaches occur in virtually every state, health care providers in Texas have the added burden that the state has led the country in total hacking breaches reported to HIPAA for four of the past five years. In light of other rulings similar to those in California and Arizona, it is no surprise that Texas hospitals have recently been devoting more resources to cybersecurity. The added protection seems to be working—data shows that despite Texas often being in the top two states in terms of total hacking attempts over the past five years, it is further down the list when it comes to individual records actually breached.

Since it is becoming increasingly common for state courts to find HIPAA as the patient privacy standard of care for private rights of action, health care providers should re-evaluate, establish and enforce HIPAA compliance and training programs within their organizations. Otherwise, not safeguarding against HIPAA violations could result in substantial penalties against an organization.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa today!

As the daughter of a periodontist, Courtney P. Cowan has been fascinated by the health care field since childhood. She often accompanied her father to his office, where she developed an appreciation for physicians and their respective practices. Having absolutely none of the dexterity that is required to be a surgeon, however, Cowan instead decided to pursue a degree in business while attending Baylor University. It wasn’t until she was required to take a business law course that she discovered her passion for the law. After graduating from Southern Methodist University Dedman School of Law, Cowan serendipitously connected with ByrdAdatto and now assists clients by combining her business background with her enthusiasm for health care and the law.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Medical Board of California Issues Warning for Hair Restoration Technicians

Posted By Administration, Friday, September 13, 2019

hair restoration

By Michael Byrd, JD, partner, ByrdAdatto

The Medical Board of California (MBC) has warned physicians against using unlicensed persons for hair transplant procedures in the summer issue of its newsletter. (The issue is available here, with the article appearing on page 12.) It states that the MBC has become aware of many physicians or clinics that are employing trained but unlicensed persons, referred to as medical assistants (MAs), to perform or assist with hair transplant procedures. The article gives the example of MAs creating holes or slits in the patient’s scalp using a needle, scalpel or other device as being prohibited. While it does not explicitly state that this is the case, its warning would seem to apply equally to harvesting follicles as it would to preparing the follicle implantation sites.

In California, MAs have a very limited scope of tasks they are permitted to perform. They are permitted to perform only “basic administrative, clerical and technical supportive services,” with several procedures specifically authorized in 16 CCR § 1366. With the exception of puncturing skin or vein for purposes of drawing blood, their other authorized tasks are non-invasive and include tasks such as trimming nails and ear lavage. Likewise, the MBC has stated that MAs may not inject fillers, nor may they fire lasers. The article warns that physicians who violate this restriction are aiding the unlicensed practice of medicine, which can carry penalties of fines or imprisonment. If you are employing MAs in your practice, you will want to carefully review what tasks you are assigning to them and ensure that the delegations are legally permitted.

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 become the next med spa success story.

Michael S. Byrd is a partner at the law firm of ByrdAdatto, a national business and health care boutique law firm with offices in Dallas and Chicago. As the son of a doctor and entrepreneur, he has a personal connection to both business and medicine. He has blended these life experiences to become a leading advocate for doctors and dentists throughout the United States. He routinely lectures at continuing education seminars on the various business and legal issues that professionals face. Outside of health care, Michael has used these same skills to handle sensitive and complicated business matters for entrepreneurs, business owners, attorneys, CPAs, high-net-worth individuals and public figures. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2019), was named a Top Rated Lawyer by the Dallas Morning News (2016), and has been recognized as a Best Lawyer in Dallas in health care by D Magazine (2013, 2016-2019).

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

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How the Texas Corporate Practice of Medicine Relates to Medical Spa Ownership

Posted By Administration, Tuesday, September 10, 2019

medical law

By Patrick O’Brien, JD, legal coordinator, American Med Spa Association

Recently, AmSpa has been getting a lot of emails and calls telling us they have been informed that in Texas, unlicensed people can own a medical spa and simply hire a medical director. This contradicts our information, as well as ByrdAdatto’s research on the subject: Texas’ corporate practice of medicine (CPOM) policy generally prohibits non-physicians, lay corporations and other entities from employing a physician to practice medicine. We understand how there can be some confusion, as the various authority and elements that make up the legal basis for Texas’s CPOM policy are scattered in a number of places. However, we wanted to provide our Texas members with some additional information on this, because it is important to stay in compliance with the policy; failing to do so can open the physician up to discipline for abetting the unlicensed practice of medicine, and can subject the non-physician owners to fines and penalties as well. You only need to look to the Texas Medical Board’s June 27, 2019 press release for examples of the board taking action. In one instance, a physician was prohibited from performing, supervising or delegating medical spa procedures for five years for aiding the unlicensed practice of medicine and lending his license to a medical spa. In two other cases, unlicensed medical spa owners entered into agreed cease-and-desist orders with the board; they had been engaging in the unlicensed practice of medicine by advertising and providing medical cosmetic procedures. This article will explore some of the main sources of this policy and attempt to dispel some of the confusion.

A discussion of this topic should begin with the Texas Occupations Code Chapter 3 Subtitle B, collectively referred to as the “Medical Practice Act.” Section 155.001 requires that a person must hold a license to practice medicine. Section 155.003 make it clear that only a person who has completed the required educational steps may hold a license to practice medicine. Section 165.152 make it a violation subject to penalties for a person to practice medicine in violation of the Medical Practice Act. Section 165.156 also make it a violation for a “person, partnership, trust, association or corporation” to use any letters, words or terms in any manner that indicate it is licensed to practice medicine if it is not, in fact, licensed to practice medicine. In Section 164.052, the code states that a physician is subject to discipline if he or she “directly or indirectly aids or abets the practice of medicine by a person, partnership, association or corporation that is not licensed to practice medicine by the board.” Section 165.155 prohibits a physician from paying or rewarding any person or entity for soliciting or securing patients. Taken together, it is clear that an unlicensed person, corporation or other entity cannot advertise that they practice medicine or offer medical services, and they cannot simply hire a physician to lend a license to their business.

Now, there are a number of exceptions to this general prohibition on employing physicians. The Texas Medical Board has adopted Rule §177.17 and provided a FAQ article on CPOM that provides a helpful summary of the information and possible exemptions. Rule §177.17 lists various exempt hospitals, non-profits and institutions. However, those entities are not applicable to a privately owned medical spa. Corporations and other entities properly formed and owned under Title 7 (Professional Entities) of the Texas Business Organizations Code are also exempt. A properly owned professional medical corporation may hire physicians and offer medical services.

The Texas Medical Board’s FAQ also mentions that physicians may enter into an independent contractor relationship, though it is a question of law and facts whether it is a permitted independent contractor or a prohibited employment relationship. Under 151.055, hospitals may enter into independent contractor agreements with physicians. However, for other physician and non-physician relationships the navigation can be incredibly tricky. Any independent contractor arrangement must still comply fully with the Medical Practices Act, as well as not fall into any aspects that would make it a prohibited employment relationship. Each of the listed court cases and attorney general opinions addresses different aspects used in determining independent contractor status from employment relationships. Some of the issues examined are the flow of funds, setting of fees, ownership, control over medical decisions, control over services or employees, and advertising. This means that even if your agreement says “independent contractor,” it may still be a prohibited employer/employee relationship if it does not satisfy all these elements.

For example, in the case of F.W.B. Rockett v. Texas State Board of Medical Examiners, the physician saw patients and reviewed X-rays for a non-physician-owned clinic; for his services, he was paid a flat monthly fee. In this case, the physician lost his license because he was permitting an unlicensed person to practice medicine. Similarly, in Flynn Brothers, Inc. v. First Medical Associates, the physician claimed to be an independent contractor, but the court found him to be an employee because, among other reasons, the non-professional entity retained two thirds of the physician’s collected fees.

Taken all together, the case law and statutes form a complex balancing act. The Texas Medical Association recently published a white paper detailing its explanation of the doctrine, and it largely reflects the views of AmSpa on the matter. Additionally, the medical service organization (MSO) model allows medical spas in Texas a way to navigate these situations. If you are not familiar with the MSO model, see articles about it here and here, and the concept will be covered by an attorney from ByrdAdatto at the upcoming AmSpa Medical Spa & Aesthetic Boot Camp in Dallas. Because of the highly technical nature of the CPOM, the board’s FAQ recommends that you consult an attorney before entering any actual arrangement. Also, do not base your business plan on any article, even—and especially—this one. You need specific and tailored advice from an attorney who is intimately familiar with the Texas CPOM, professional organizations law and medical spas.

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

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Can I Reward My Medical Spa Patients for Referring a Friend?

Posted By Administration, Monday, September 9, 2019

gift card exchange

By Robert J. Fisher, JD, ByrdAdatto

We at ByrdAdatto receive numerous questions each week from providers, medical spas, wellness counselors and other businesses in the aesthetic space. These questions range from entity structuring to employee disputes to lease negotiations, but questions relating to patient reward programs for referring friends are among the most frequently asked.

Patient referral rewards come with multiple overlapping layers of laws and regulations. In order to understand the risk you might incur by using these referral programs, it is critical to seek advice from a health care attorney before implementing a rewards system or referral incentive initiative.

The federal Anti-Kickback Statute is the starting point for understanding the implications for rewarding a patient for referring a friend. This law states that providers cannot offer remuneration in cash or in kind to induce the referral of a business or service covered by a federal health care program. Stated another way, a provider cannot give a person gift cards, cash, discounted services or anything else of value in exchange for referrals when federal insurance programs, such as Medicare and Medicaid, are involved. The federal Anti-Kickback Statute likely does not apply to your aesthetic practice, since such aesthetic practices are typically cash-based, but it serves as an important building block.

Most states have their own version of an anti-kickback law that uses the federal language as a base, but broadens the restrictions to varying degrees. For example, Texas, New York, Florida and California all have laws that prohibit providing remuneration to a person for referrals, regardless of whether patients are paying with cash or insurance. In these states, giving a patient cash, gift cards or generally anything of value for referring a friend will create the risk of violating the state anti-kickback law. On the other hand, Illinois law only prohibits remuneration for referrals when insurance is involved and does not regulate paying for referrals where the practice is cash-based.

Finally, the regulatory boards—medical boards, nursing boards, etc.—can issue their own rules and regulations that tighten or otherwise modify state anti-kickback laws. Continuing the Illinois example, while its state law does not prohibit providing remuneration for referrals when cash payors are involved, the medical board has opined that it views this practice as unprofessional and unethical. This can result in a medical provider being at risk for loss of license, reprimands, fines and more from the medical board if he or she pays for referrals.

The complexity of health care laws and the importance of identifying the laws applicable to your practice make the risk of creating a patient referral program without talking to a health care attorney too great. There also may be alternative solutions to boost patient numbers, such as installing membership discount systems, that avoid creating a regulatory headache.

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 become the next med spa success story.

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

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Join AmSpa at the Dallas Medical Spa & Aesthetic Boot Camp

Posted By Administration, Wednesday, September 4, 2019

dallas texas

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

Starting next Saturday, September 14, AmSpa will host its Dallas Medical Spa & Aesthetic Boot Camp at the Doubletree Dallas Campbell Centre. We’re extremely excited for the opportunity to help medical aesthetic professionals in the Lone Star State develop their practices, and we can’t wait to once again visit Big D. There’s still time to register for the event—just click here to sign up.

Here is a quick overview of the program:

Saturday, September 14

The Boot Camp begins at 8 a.m. with a continental breakfast, followed at 8:30 a.m. with my opening keynote. From there, we will move into the main program:

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 10:45 – 11:45 a.m.: The Lessons, presented by Louis Frisina—Every medical spa is different, but the successful ones share several common traits. In this session, Business Strategy Consultant Louis Frisina discusses the qualities that are typically found in practices that bring in a significant amount of revenue.
  • 12:45 – 1:30 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), Bobby Calhoun (Environ Skincare), and Jamie Bergeron (Bellus Medical) and Page Piland (Galderma)—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Bradford Adatto (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4:15 – 5 p.m.: The Treatments, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and find out how to best determine which treatments are right for you based on the state of your practice.
  • 5 – 6 p.m.: The Digital Marketing Ecosystem, presented by Tim Sawyer (Crystal Clear Digital Marketing)—Find out how to effectively spread the word about your medical aesthetic practice and how best to determine what’s working and what’s not. Your practice’s digital presence is more important than ever before, and curating it should be a top priority.

Saturday will wrap up with a cocktail reception from 6 – 7:30 p.m.

Sunday, September 15

Once again, the Boot Camp begins at 8 a.m. with a continental breakfast.

  • 8:30 – 9 a.m.: Anatomy of a $5-Million Med Spa, presented by Alex Thiersch (AmSpa)—Have you ever wondered what the difference is between your medical spa and one that’s mega-successful? It might be less significant than you think. This presentation will show what a $5-million med spa is doing right—and what you might be doing wrong.
  • 9 – 10 a.m.: The Financials, presented by Bryan Durocher (Durocher Enterprises)—At the end of the day, the money you’re bringing in is the most important measure of your practice’s success. This presentation will, among other things, demonstrate how to properly develop a budget and use metrics to determine your med spa’s strengths and weaknesses.
  • 10:30 – 11:30 a.m.: The Long-term Revenue, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—Simply being successful isn’t enough for a medical aesthetic practice; you have to know how to maintain and grow your success. In this session, Brandon and Jenny will show you how to build patient loyalty and move your business forward.
  • 11:30 a.m. – 12:15 p.m.: The Consultation, presented by Terri Ross (Terri Ross Consulting)—As the old saying goes, you never get a second chance to make a first impression. Learn how to put your best foot forward with effective patient consultations—and how to turn them into consistent business.
  • 1 – 2 p.m.: The Marketing Plan and Social Media, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—This session will help you determine how to most effectively market your medical aesthetic practice using both traditional methods and cutting-edge techniques.
  • 2 – 3 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.

Also, you’ll have the chance to visit with a number of exceptional vendors during this event. Attend the Seattle Medical Spa & Aesthetic Boot Camp to check out the latest and greatest from the following companies:

We hope you can join us in Dallas next weekend. This Boot Camp is a tremendous opportunity to get a medical aesthetic business started off on the right foot, as well as learn how to take an already successful business to the next level. Click here to register!

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

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UPDATED—The Hyaluron Injection Pen: Is It Legal? Who Can Use It?

Posted By Administration, Monday, August 26, 2019
Updated: Monday, August 26, 2019

medicine

By Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

ORIGINAL STORY [7/1/2019]: The Hyaluron Pen is a new injection device that is gaining a lot of buzz overseas. It claims to deliver injections of fillers—typically hyaluronic acid—in a less invasive and painful way than typical needles and syringes. As these products make their way to the U.S., it must be noted that currently, no device is U.S. Food and Drug Administration (FDA)-approved for injecting hyaluronic acid and other fillers in this way. We have seen several ads and notices that offer to sell these devices and provide training for them. Before you make a purchase, you may want to know: Is it legal? And can you legally perform this procedure?

When a medical device gains FDA approval, it can legally be marketed for that specific approved use. We have discussed issues with using approved devices in unapproved ways—so-called “off-label use.” In this case, we were unable to locate an FDA marketing application for a hyaluronic acid injector. According to an FDA guidance document on needle-free injectors, this type of device would likely by regulated by FDA’s Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research as a “combination product.” General-use needle-less or jet injectors are regulated as Class II medical devices. In general, without an FDA marketing or premarket approval, a product manufacturer cannot legally sell or advertise a device for unapproved use; this marketing prohibition extends to purchasers of the product as well.

Since this product is so new, there are no specific laws that directly address who may use it. Instead we must look at how similar procedures and technologies are treated. Unlike a traditional filler injection that uses a hypodermic needle and syringe, this device uses a high-pressure jet to inject the fillers through the skin without the use of a needle. This makes the device similar to other needle-less and jet injection systems that sometimes are used to deliver vaccines and other medications.

While the injection technology is novel, the treatment is fundamentally the same as traditional filler injections. Although there is no needle being used, the skin is still being “pierced” by the jet of hyaluronic acid. As such, we believe these pens will follow the same or similar rules as injecting filler using traditional syringes. Therefore, the use of these devices is a medical treatment, so a good-faith exam must be performed before the procedure, and if the physician is not administering the treatment him- or herself, it must be properly delegated. Unfortunately for practices that would like to use unlicensed practitioners to use pen injectors for fillers, this takes the procedure out of the scopes of practice for aestheticians and most LVNs.

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 become the next med spa success story.

UPDATE [8/26/2019]: AmSpa has become aware that the Texas Medical Board (TMB) has issued at least one and possibly more compliance letters regarding Hyaluron Pens. We don’t have all of the details on this issue, but it appears to have stemmed from health inspectors noticing a Hyaluron Pen at an aesthetician’s station during a salon inspection.

In the article below, we noted that even though these pens do not use needles, their use is considered the practice of medicine, and these procedures need to be performed by appropriate persons under medical supervision. This TMB letter, at least for Texas, confirms that belief, and we see no reason other states would take a different view.

It is our understanding that Hyaluron Pens are being promoted through seminars and trainings; these trainings seem to be marketed primarily to aestheticians and cosmetologists. Remember, before you spend any money or time on any training, it is important to verify that you will be legally able to perform the procedure. (See here for more information.)

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

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How Practices Can Effectively Use Social Media

Posted By Administration, Thursday, August 22, 2019

filming surgery

By Renee E. Coover, JD, ByrdAdatto

Social media in plastic surgery practice continues to explode, driven by the marketing opportunities created by the public’s unabashed desire for before-and-after photos and live patient surgeries. But with this reliance on social media to market and advertise, a plastic surgeon’s practice assumes often unknown risks. In a recent Los Angeles Magazine article, Beverly Hills Plastic Surgeon Ashkam Ghavami, MD, who has almost 400,000 Instagram followers to his practice, acknowledged the challenges in balancing ethics with entertainment. According to Ghavami, “Because social media is the most valuable marketing tool of our trade, some surgeons post deceptive before-and-after photos of patients on social media. This creates an uneven playing field and, worse, harms the potential patients who are trying to choose their surgeon.”

Questions arise as to what is appropriate or legal for a physician to advertise on social media: Does it require patient consent? Who ultimately owns the content that is posted to social media?

Here are some key compliance considerations for social media in your plastic surgery practice:

  1. Obtaining patient consent. Patient consent for social media use should be separate from other consents. Consent must deal with the circumstances of the social media use. A wide range of circumstances that can impact consent. Before you ever post before-and-after photos of a patient’s Brazilian butt lift, you must obtain written consent from your patient. Likewise, if your patient brings in a friend or relative to live-stream a video of his or her medical procedure, it still requires direct consent from the patient. Without patient consent, a plastic surgeon puts his or her license at risk by posting patient photos or videos to social media.
  2. Physician advertising rules. Physicians are subject to specific state medical board advertising rules that control the messages they advertise so as not to be deceptive or misleading to the public. The Federal Trade Commission (FTC) also regulates physician advertising. (For more on this, read Michael Byrd’s recent article “FTC Focuses on Social Media for Truth in Advertising.”) The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) also regulate physician advertising; for example, check out this article, which discusses the first code of ethical behavior for sharing videos of plastic surgery on social media, published by Northwestern plastic surgeon Clark Schierle, MD, and presented at the ASPS annual meeting. Using “enhanced” before-and-after photos or stock image photos, using models, allowing staff to post their personal beliefs and opinions on your social media accounts, and communicating directly with patients via social media are just a few ways plastic surgeons get in deep trouble with physician advertising laws.
  3. Ownership of social media. The ownership of content posted by employees often is unaddressed. For example, physicians and nurses often post before-and-after photos to their personal social media accounts. This creates both potential infringement issues and patient privacy issues. As attorney Bradford Adatto noted in his recent article, “5 Key Details Every Plastic Surgeon Should Know About Their Employment Agreement,” relating to plastic surgeon’s employment agreements, there are a substantial number of patient privacy laws to understand before posting patient photos to social media. Further, if the practice intends to keep all social media content as its property, whether it is posted to a practice account or an employee’s personal account, this needs to be addressed in a social media policy.
  4. Social media policy. A variety of issues arise when using social media to advertise medical services; thus, it is crucial for every plastic surgery practice to develop a social media policy to address issues such as employees’ use of social media and ownership of the content. The social media policy also should be mentioned in your employee handbook. Simply having a social media policy is not effective unless all staff have been informed of the policy and management is trained to implement and enforce the policy.

All this information also applies to medical spas. To learn more about how to effectively use social media in a medical aesthetic setting, consider attending an AmSpa Medical Spa & Aesthetic Boot Camp. Each Boot Camp features a session on social media, as well as useful information about all aspects of running an effective medical aesthetic practice. AmSpa Members save when registering for Boot Camps—click here to learn how to join.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Should Your Medical Spa Tell Yelp to Buzz Off?

Posted By Administration, Thursday, August 15, 2019

negative reviews

By Jeff Segal, MD, JD, ByrdAdatto and Medical Justice

Have you heard of Botto Bistro? It’s a pizzeria in the Bay Area. Chef Davide Cerrentini, who emigrated to the US in the ‘90s, opened the restaurant’s doors in 2009.

Cerrentini is famous for asking happy diners to give him a one-star Yelp review. That’s right—one star.

Botto Bistro has accrued thousands of these reviews, and was at one time ranked as the worst-rated restaurant on Yelp. To Cerrentini, that was a badge of honor.

By the way, he is immensely successful.

Here’s what happened, and why Cerrentini embraced the lowest of the low reviews.

Shortly after the restaurant opened, he received calls from Yelp salespeople. They suggested he buy ads on Yelp. When he told the salespeople, “No thanks,” he observed that some recent five-star reviews had disappeared.

“I came from Italy, and know exactly what mafia extortion looks like,” he said. “Yelp was manipulating reviews and hoping I would pay a protection fee. I didn’t come to America and work for 25 years to be extorted by some idiot in Silicon Valley.”

Cerrentini then turned to the dark side. He wrote his own five-star reviews to replace the real ones that were removed. He also wrote negative reviews of neighboring restaurants.

Ultimately, he gave in. He started spending $270 per month to advertise on Yelp.

After six months, he pulled the plug. He found the service “useless” and cancelled his advertising. Then, his star rating dropped.

In the spring of 2014, after turning down another Yelp salesperson, Cerretini claims that four five-star reviews were filtered from his page, and three one-star reviews were suddenly catapulted to the top of the page. For the chef, this was the final straw.

“What if I don’t give a s*** about reputation?” he said. “What if I take away their power by actually making it worse?”

One morning in September 2014, he placed a simple sign in front of Botto Bistro: “Give us a one-star review on Yelp and get 25% off any pizza! Hate us on Yelp.” (The discount was later increased to 50%.)

The next day, business exploded. Cerretini was making money hand over fist. Botto Bistro quickly had more than 2,000 reviews. Most of the ratings praised the food and the service, and then gave it one star.

“Botto Bistro sucks,” wrote one reviewer. “Delicious food priced fairly. One star.”

“Seriously, who puts meat on pizza?”

“Don’t try the pizza, it’s so good you will come back every night, it completely ruined my social life cause each night I only want to go there. I hate this place.”

“I ordered meatballs and they were served upside down.”

A Yelp support member sent Cerrentini an email chiding him for offering incentives in exchange for a review. That was a violation of Yelp’s terms of service. Hmm.

Other business owners have followed Cerrentini’s lead. Some have posed “No Yelpers” signs in their windows.

A new documentary called Billion Dollar Bully catalogues the Yelp controversy. Click here to check out the trailer.

Cerrentini has been very successful with his high-risk gambit. It took a lot of guts.

“Most people are not ready to stop caring about reviews—it’s a big risk,” he said. “But I’d rather sit alone in my restaurant then get business from Yelpers.”

What do you think? Particularly related to Yelp in the health care space?

We understand the temptation to ignore outlets like Yelp is strong, but we urge doctors to resist the urge. By ignoring a problem post on Yelp, you are denying patients access to a counter-narrative. And if there is no counter-narrative, there’s an increased risk the doctor will be defined by that problem post.

This is a bad outcome—patients prematurely reject doctors who are qualified to treat them, and doctors miss the opportunity to treat patients.

So what’s the remedy? We advise doctors take a proactive approach. Before you get blasted online, populate the internet with accurate descriptions of your quality of care. In this way, when the inevitable happens, you have a defense against the angry, the uninformed and the malevolent.

Medical Justice has designed a program that addresses these obstacles. The program exists for two reasons—the first is to keep your online reputation out of the crosshairs, and the second is to help new patients find you.

Jeffrey J. Segal, MD, JD, is a neurosurgeon turned serial entrepreneur turned attorney at ByrdAdatto who has literally been in both business and medicine. Segal was a neurosurgeon in private practice before beginning the second phase of his career as a serial entrepreneur in the health care field. He then founded or co-founded four separate health care startups. Segal lives and breathes health care and understands it viscerally.

Tags:  Business and Financials  ByrdAdatto  Med Spa Law 

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How Do You Name a Medical Spa in New York (And Elsewhere)?

Posted By Administration, Wednesday, August 7, 2019

new york city

By Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

Choosing a name for a new business is one of the more difficult decisions entrepreneurs have to make, and this is especially true in the medical aesthetic industry. A medical spa needs a unique and memorable name that conjures thoughts of vitality, health and beauty, but it also must follow the rules for naming medical and professional entities. As we’ve discussed in the past, most states consider medical spas to be medical practices, and every state has its own rules or standards when it comes to naming and advertising medical practices.

New York state has particularly stringent rules regulating physician advertising. Fortunately, the New York State Office of the Professions provides a useful resource for navigating the rules for naming a professional entity in the state. While these rules are specific to New York, the concepts are similar in many other states.

The requirement that the name of a professional entity must appropriately describe the profession and the professional service being offered is the first and largest hurdle to overcome. In the medical spa setting, the professional services being offered will be “medicine” or “medical”—or, for independent nurse practitioners, “nursing.” But these terms are very generic and don’t accurately convey the type of experience and services offered in most medical spas. To provide a better description, you might be tempted to use terms such as “aesthetic,” “esthetic” or “anti-aging” to describe medical spa services, but these terms fall under the “specialty area” naming rules in New York. Essentially, if you want to use a special branch of a profession—in this case medicine—the Office of the Professions requires that you submit proof of certification in that specialty practice. While physicians may obtain board certifications in dermatology and plastic surgery, practicing in the area of aesthetic medicine does not come with specialty board certifications.

Could you add “medical spa” to the end of the name for your professional entity? Using the term “medical spa” reflects the required “medical” professional practice area, and “spa” makes it clear to the public what types of aesthetics services you plan to offer. This seems like a good alternative, but, unfortunately, the term “spa” in connection with “medical” are among a list of words specifically prohibited as being misleading in New York. And it isn’t only “misleading” terms that are prohibited: Professional entity names cannot suggest an affiliation with another entity or imply professional superiority. Therefore, whether intentional or not, the chosen name can’t be too similar to the name of another entity, and it also can’t include ideas such as “best,” “advanced” or “expert.”

To add an additional twist, New York medical spas face the same restrictions when choosing an assumed name under which to practice, also known as a “doing business as” or “d/b/a” name. Many states have particular rules in naming the registered professional entity, but they often allow more flexibility in using assumed names. This is not the case in New York—the assumed names of professional entities must follow the same naming requirements.

While New York is particularly strict, each state has its own rules that govern business naming, especially for businesses that provide medical services. Before you spend valuable time and money on signage, web design, advertising and marketing, it is important make sure that you choose a name that complies with your local and state laws. If you want to learn more about effective medical spa marketing and business practices, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps.

Tags:  Business and Financials  Med Spa Law  Med Spa Trends 

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