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How Your Medical Spa Can Address Negative Patient Reviews

Posted By Administration, Monday, September 30, 2019

one star

By Kita McCray, JD, ByrdAdatto

Benjamin Franklin said, “It takes many good deeds to build a good reputation, and only one bad one to lose it.” It’s been a couple of centuries since Franklin made this statement, yet the same remains true today. It is especially true in health care, where patient dissatisfaction can be amplified with just a few keystrokes and the click of a mouse.

On one hand, the internet has expanded our accessibility to one another and information; on the other hand, it provides a medium for bad reviews and feedback to travel further and faster than our reputations can keep up with. As a result, many patients think they “know” their providers before they ever meet them. So, what’s the solution when that one dissatisfied patient tries to start a fire by posting a negative review of you or your practice? The answer is simple: Dilute the fire—the solution to pollution is dilution.

Jeff Segal, MD, JD, a ByrdAdatto partner and CEO of Medical Justice, has built a simple strategy for dealing with negative patient reviews. Specifically, when writing a response to a negative patient review, you must remember these five golden rules:

  1. A model response shows the practice is reasonable and isn’t engaged in a debate;
  2. A model response educates the public;
  3. A model response addresses the concerns raised in the review;
  4. A model response takes the conversation offline; and
  5. A model response does not address the author directly.

Segal further advises that the person or employee who is responsible for locating and responding to negative reviews should commit to these rules in order to dilute or drown out the dissatisfied voices in the crowd. These rules also will help you to avoid potential violations of HIPAA or professional licensing board regulations that may cause regulators to perceive the filtering of negative reviews as false and deceptive advertising.

Remember that it takes two flints to make a fire. Engaging in a debate with a dissatisfied patient in a public way is a bottomless pit. Once you fall in, it can be difficult to pull your reputation out.

To learn more 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.

Kita McCray’s decision to become a lawyer was solidified in fourth grade after job shadowing a local lawyer in her hometown of Ferriday, Louisiana. In college, Kita dedicated all her enthusiasm and energy to becoming well-read in classic English literature before attending law school. But while working as a public health graduate researcher, she developed an interest in health law and policy, and decided to focus her legal studies toward health care law.  Today, Kita brings the full scope of her multidisciplinary background to assist clients with their business and health care needs.

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

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Medical-grade Skin Care vs. OTC Skin Care: What’s the Difference?

Posted By Administration, Monday, September 23, 2019

skincare

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

As anyone who has to deal with chronic pain will tell you, there is a world of difference between prescription pain-relief drugs—such as oxycodone and hydrocodone—and over-the-counter (OTC) pain-relief drugs, such as ibuprofen. The U.S. Food and Drug Administration (FDA) categorizes these drugs according to their active ingredients. Hydrocodone, for example, is an opioid, and it has a significant effect on certain receptors in the body, while ibuprofen merely inhibits enzymes, which produces a much less intense reduction in pain. Of course, opioids can be highly addictive, so requiring a prescription also (theoretically) keeps them out of the hands of people who would abuse them.

FDA categorizes skin care products somewhat similarly, and medical aesthetic professionals should know why some products require prescriptions, while others are more widely available. Understanding the difference can not only help medical aesthetic practices provide better patient care, but may also affect their bottom lines.

Cosmetics vs. Drugs

The FDA addresses the use of drugs and cosmetics under the Federal Food, Drug, and Cosmetic Act, which was enacted in 1938 and has been amended numerous times since then. The text of this act draws a distinction between “cosmetics” and “drugs” that provides relatively definitive guidance on this topic. A cosmetic is defined as a product that is “intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Obviously, many products that are commonly used in medical spas and medical aesthetics fall under this category.

Drugs, meanwhile, are “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the legal difference between a cosmetic skin care product and a skin care drug is the product’s intended use.

“If you say you're going to eliminate fine lines and wrinkles, that claim—which alters the form and function and structure of the body—is a medical claim and, therefore, that product is considered a drug by the FDA. It has to be approved and regulated, and there's a long process to get through,” explains Rob Trow, CEO of DermaConcepts, the exclusive U.S. distributor of Environ Skin Care. “If you say that the skin care product will improve the appearance or look of fine lines and wrinkles, that's not a medical claim, and therefore it's not a prescription product and can be sold without it.” Drugs must be approved by the FDA, while cosmetics do not need approval, so a few words in a product’s description can make an enormous difference for the manufacturer.

“If a product says [it] will produce collagen and elastin, that's a product that affects the form and function of the body and is a medical claim, and therefore the product should be classified as a drug and go through a very complex and costly approval process,” Trow says. “If you look at the ads for skin care, you'll see many, many ads make those claims, even though they're not allowed to. But most skin care companies qualify the claims with adjectives that talk about ‘the look of, the feel, the appearance of,’ rather than affecting the change.”

According to Carl Thornfeldt, MD, founder and CEO of Epionce: “Many cosmetic products claiming they are effective for treating skin disease are mislabeled, basically not complying with FDA regulations. Moreover, many have no safety or efficacy studies.”

The concentrations of certain chemicals and compounds in a product also can determine whether it is a cosmetic or a drug. For example, a product with a 2% concentration of hydroquinone is considered cosmetic, while one with a 4% concentration is considered a prescription drug.

“[Some] medical skin care products—the technologies that proved themselves in performance and safety—may later move toward implementation in OTC products. [These would be] potentially less concentrated ones, but utilize proven clinical technology,” says Nikolay Turovets, PhD, CEO for DefenAge Skincare. “The most famous example, of course, are retinols.”

Some cosmetic manufacturers choose to submit their products for FDA approval and create their products according to FDA regulations, but they are not required to do so.

“There are certain cosmetic companies that have their own factory, that manufacture in clean rooms with nitrogen blankets, red and yellow light, pressurize the air system, and it's like going into an operating room where everybody is gowned and booted,” Trow says. “Some cosmetic companies use airless pumps, because if you let air and light into a product, you destroy its efficacy. So there are non-prescription products that are manufactured as stringently as prescription drugs. Unfortunately that has nothing to do with requirements by law, but rather the values and the investment in that process by the specific skin care company.”

Degrees of Drugs

If a skin care product is categorized as a drug, it falls into one of two categories: OTC or prescription. OTC drugs are typically available to anyone who wants to purchase them, although the sales of a small number of OTC products are restricted to a degree due to their active ingredients. (Pseudoephedrine, for example, is kept behind drugstore counters because its active ingredient is commonly used in the illicit manufacture of methamphetamines.) Only a few types of skin care products fall into the OTC drug category; typically, they are sunscreens and other general skincare products.

“There are many great product lines available in retail stores over the counter,” says Barbara Pestana, director, U.S. medical sales and marketing for NeoStrata Company, Inc. “OTC products can support general skin care needs, such as cleansing, hydration and sun protection.” Although OTC products are not as heavily regulated as prescription drugs, they still are held to high standards.

“OTC drugs must use pharmaceutical-grade [ingredients] and be manufactured in an FDA-inspected, [good manufacturing practice]-compliant facility,” explains Thornfeldt, whose company manufactures a number of OTC skin care products. “OTC drugs must also comply with FDA over-the-counter-drug monographs for the chemicals themselves, the concentration ranges, and the rules regarding claims for disease or conditions the active ingredient treats.”

It is not impossible for a drug to go from prescription to OTC, though it is not terribly common. Widely used drugs, such as cetirizine (Zyrtec), fexofenadine (Allegra), famotidine (Pepcid) and omeprazole (Prilosec) have made the switch, as have a handful of smoking-cessation aids and hair-growth products. Even ibuprofen was formerly only available via prescription.

“Pretty often, the most innovative, groundbreaking and revolutionary technologies are initially offered to market through medical distribution channels,” says Turovets. “For example, almost 20 years ago, when Dr. [Richard] Fitzpatrick introduced SkinMedica to the market, it was mind-blowing innovation—use of growth factors produced by living human cells in a laboratory to stimulate skin.”

However, while OTC products can be used without supervision, there are a number of advantages for patients who consult with physicians to develop a course of skin care treatment, including the use of prescription products.

“These products are often sold and recommended by a medical professional who will examine and diagnose skin care needs and create a targeted program to help patients achieve their goals,” Pestana says. “The program will likely include in-office devices and peels, along with a customized home-care regimen to enhance the effects of the procedures. Medical-grade skin care often provides protocols for both in-office procedures and home care that can be personalized to the needs of each patient.”

Expanding Understanding

Operators of medical spas and medical aesthetic practices should have a good understanding of the products that are being used in their practices and work with patients to fully understand their current OTC or prescription skin care regimens and how they can be adapted to bring about the best possible result for the patient.

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  Med Spa Law  Med Spa Trends 

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How Your Medical Spa Can Legally Use Telemedicine

Posted By Administration, Friday, September 20, 2019

telemedicine

By Bala Mohan, JD, ByrdAdatto

Telemedicine is gaining popularity and acceptance across the United States. Some of the benefits of telemedicine include easing health care access to patients in remote and underserved areas, increasing cost-effectiveness, efficiently delivering health care service, and broadening the opportunity to receive secondary opinions. Telemedicine, in a nutshell, is the provision of health care services using telecommunication from a health care practitioner in one location to a patient in another. However, telemedicine compliance is tricky and varies from state to state. In addition to state laws, telemedicine also is subject to federal reimbursement, patient privacy and confidentiality laws.

This article will focus on the basic state law compliance considerations and general rules for providing telemedicine in your medical practice; however, any decision to provide telemedicine requires deeper scrutiny of the laws and regulations.

  1. Licensure. Clients commonly ask if they can provide telemedicine to a patient in another state. Typically, the practitioner providing the service must be licensed in the state where the patient is physically located. However, as with everything else in law, there are exceptions. For example, Maryland exempts physicians licensed in an adjoining state from obtaining a Maryland license, and Minnesota has a provision for physicians not licensed in the state to practice medicine in Minnesota via telemedicine by meeting certain telemedicine registration requirements. Appropriate physician licensure is a necessity when practicing medicine across state lines because providing telemedicine services in a state where the practitioner is not licensed can result in disciplinary action—including civil or criminal penalties—for the unlicensed practice of medicine.
  2. Standard of care. Practitioners using telemedicine will be held to the same standard of care that would apply to the provision of health care services in an in-person setting. To meet the standard of care, the practitioner must, at a minimum, establish a valid practitioner-patient relationship, provide quality health care service, obtain appropriate informed consent, document and maintain accurate patient medical records, and abide by the patient and medical record confidentiality standards required by law. Performing a proper initial consultation is a key aspect of establishing the practitioner-patient relationship; thus, an appropriate patient examination or evaluation is an important part of meeting the standard of care. Physicians must take the patient history and conduct a thorough evaluation of the patient’s medical condition prior to diagnosing the patient and prescribing the treatment plan.
  3. Establishing a valid practitioner-patient relationship. As the initial step, telemedicine laws usually require the practitioner to establish a valid practitioner-patient relationship, if one does not already exist. The legal requirements and process to establish this relationship vary by state. Generally, if a prior practitioner-patient relationship does not exist, it can be established via telemedicine using appropriate means. Some states may have restrictions as to the physical location of the patient for the patient evaluation or the telecommunication modalities that can be used in practicing telemedicine. However, filling out online questionnaires, telephone calls or text messages alone are not sufficient to establish the practitioner-patient relationship. Generally, acceptable telecommunication means use real-time streaming audio-visual technology or streaming audio coupled with store-and-forward technology.
  4. Reimbursement. Reimbursement for telemedicine services also varies widely amongst states. Accordingly, health care practitioners must review their respective payor contracts prior to billing for telemedicine services. For example, Texas has parity laws that require private payors to reimburse the same way as would be required in-person. On the other hand, Florida allows the payor and provider to negotiate the reimbursement rate for telemedicine services.

As you can see, a myriad of legal issues must be considered prior to engaging in telemedicine practice. If you have specific questions about setting up a telemedicine practice, the telemedicine laws in your state, contact ByrdAdatto, and consider attending The 2020 Medical Spa Show from January 31 – February 2 at the Aria Resort & Casino in Las Vegas. The Medical Spa Show is the premier trade show for non-invasive medical aesthetics, and this year’s iteration features four tracks of curated education covering practically every topic a medical spa owner/operator would need to know about, as well as two tracks of sponsored education. Click here to register today.

Bala Mohan, JD, knew from a very young age that her choice of career would be related to science because she excelled in her biology and chemistry coursework. With a strong passion for genetics and the desire to find a cure for her mother—who was diagnosed with diabetes at an early age—Mohan obtained a Bachelor of Technology in Pharmaceutical Biotechnology. Having worked as a scientific researcher during her undergraduate studies, Mohan greatly values attention to detail and is a meticulous person. She then pursued a master’s in Entrepreneurial Biotechnology to gain knowledge about business and startups. This landed her a position with Cleveland Clinic Innovations, where she evaluated over 100 innovations and negotiated deals with potential investors. In this role, Mohan had the opportunity to interact with business and health care lawyers from multiple health care organizations, and she quickly realized that her real calling in life was to be a health care attorney. Subsequently Mohan obtained her JD and was able to pursue a career that combined all her interests—science, business, and law.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends  The Medical Spa Show 2020 

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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.



Find answers to your med spa law questions with AmSpa's State Legal Summaries.
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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.)

For legal updates and business best practices delivered straight to your inbox, subscribe to AmSpa’s email newsletter. For more information on how AmSpa can help your practice operate legally and profitably, Contact Us online or call us at 312-981-0993.

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

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