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Texas Medical Board Approves for Publication Changes to §193.17

Posted By Administration, Friday, October 18, 2019


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

The Texas Medical Board (TMB) Disciplinary Process Review Committee met in a public hearing on October 17 to consider its posted agenda. At the hearing, the board unanimously approved a motion to publish the TMB’s proposed changes to its Administrative Rule Chapter 193, Standing Delegation Orders, including Section 193.17 – Nonsurgical Medical Cosmetic Procedures, in the Texas Register. We covered some of the proposed changes discussed at last week’s meeting here. The TMB indicated that the version approved had been revised based on the feedback it received. However, the version of the rules approved at this week’s meeting won’t be available to review until they are published in the Texas Register. This publication will trigger a 30-day public comment period, after which the proposed rules will be eligible for adoption and approval at a hearing of the full medical board. AmSpa Members can click here to view additional analysis on the meeting from our lobbyist. We will keep you updated on developments once these rules are published.

Tags:  Med Spa Law  Med Spa Trends 

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A Booming Industry with Compliance Concerns

Posted By Administration, Monday, October 14, 2019

medical spa

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

Anyone involved in medical aesthetics can tell you that the industry has been absolutely booming for some time now. Whether you own a large medical spa, operate a small aesthetic practice, or sell devices to providers, chances are you’re making money. Good money.

And the industry has shown incredible resiliency and staying power, having remodeled itself after the 2008 recession into a larger, more profitable enterprise.

The numbers don’t lie. AmSpa recently released its 2019 Medical Spa State of the Industry Report, which details business, financial and treatment data relating to United States medical spas. The numbers are pretty impressive.

The report showed that the industry grew a whopping 50% in 2017 alone, with 2018 following close behind with 30% growth. Since 2011, when the industry really started to take off in its current form, it has grown an average of 28% every year. And it shows no signs of stopping. AmSpa forecasts nearly 20% growth every year for the next five years, projecting the industry will double in size from 5,400 medical spas in 2018 to more than 10,000 in 2023.

The medical spa industry is currently a $10-billion business that employs more than 53,000 people by itself (excluding other aesthetic practices such as plastic surgery and cosmetic dermatology). It is on pace to become a $20-billion industry in short order. This places it among the fastest-growing industries in America.

So what’s not to like? Strong growth, better technology, increased appetite for non-invasive techniques that make customers look younger—it all looks good, right?

Although all signs point to continued robust growth, one issue lurks beneath the surface that continues to nag at the industry as a whole. It is the one problem that the industry can’t seem to get its hands around and, until it does, it risks not only never reaching its full potential, but also causing the industry to crumble under its own weight.

I’m talking about compliance. AmSpa’s report also took a high-level snapshot of how the medical spa industry functions from a legal and regulatory standpoint. It’s critical to remember that this industry is made up of medical spas—businesses that are medical facilities governed by the same regulations that orthopedic surgeons, family practice doctors and cardiologists, for example, must follow. These rules are enforced by state medical and nursing boards, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), as well as state attorneys general. These are mandatory regulations that, when broken—even if just a little bit—can result in loss of license, hefty fines and even imprisonment.

All of these outcomes have occurred at an increasing rate during the past five years, and enforcement efforts are clearly increasing. Don’t believe me? Try typing “Botox arrest” or “med spa arrest” into Google and see what pops up.

It’s understandable, I suppose, that this industry would be slow to get on track legally. After all, with entrepreneurs and pharmaceutical companies raking in billions of dollars, it stands to reason that some shady characters would operate on the fringes. And there is no question that the applicable laws can be difficult to find, are sometimes fuzzy, and almost always are antiquated relics designed to apply to a different era of medicine. With so much new technology and so many new opportunities coming together in one industry, it is not surprising that many providers have struggled to determine what rules apply, and when. Don’t believe me? Just try calling your state medical board or nursing board.

But it’s time to get serious—and fast­—because as the industry innovates, creates and adds zeros to its bottom line, more and more opportunists take notice. Turf wars are developing between medical providers and societies. Industry executives are carving out pieces of the pie exclusively for themselves. Scammers are emerging, as are get-rich-quick schemes. And state and federal authorities are opening their eyes and actually paying attention.

Here’s the bottom line: If the medical spa industry doesn’t get its act together and focus on becoming safe, compliant and trustworthy, a reckoning will come in the form of over-regulation, truly bad publicity and public distrust—none of which are good for consistent growth.

And let’s be honest with ourselves here: Many of the rules that are being broken are not terribly difficult to wrap our heads around. Should an aesthetician with zero medical training, no oversight or supervision, and no hospital privileges be performing lip injections that can cause a patient to go blind if side effects aren’t handled properly? Should lasers that can quite literally burn a patient’s skin off their faces be administered without oversight or medical supervision?

AmSpa’s 2019 Medical Spa State of the Industry Report found that 13% of medical spas don’t perform any medical consultation prior to treatment, and that 15% of medical spas have someone other than a registered nurse, nurse practitioner, physician assistant or doctor performing injectable procedures. Five percent of medical spas admit that they have employees with no medical training whatsoever performing injections.

Take a step back and really think about those statistics. There are close to 1,000 medical spas in this country where a patient can be injected with toxin or fillers—treatments with potential outcomes that, if untreated, have been scientifically proven to cause serious side effects—without ever seeing a qualified medical professional. Or where a technician can fire a laser capable of causing third-degree burns and permanent disfigurement without any medical supervision whatsoever. Now imagine the news coverage and subsequent legal and legislative action that would result from even one individual going blind from a filler injection from an unqualified provider, or one high-profile individual being permanently scarred from laser burns. The results won’t be pretty.

Physician oversight is crucial, as are minimum training standards. Basic requirements must be universally adopted and self-enforced. The public must be convinced beyond any doubt that all medical spas are just as safe—if not safer—than plastic surgery offices or dermatology practices. AmSpa, with its partners at the law firm of ByrdAdatto, has been working tirelessly for more than six years to educate the industry on the basic requirements needed to make it safe and allow it to grow to its full potential.

Tags:  AmSpa's 2019 Medical Spa Statistical Survey  Med Spa Law  Med Spa Trends  QP 

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How the Update to the Texas Privacy Breach Notification Law Could Affect Your Medical Spa

Posted By Administration, Friday, October 11, 2019

data breach

By Jay Reyero, JD, Partner, ByrdAdatto

Target. Equifax. Facebook. Capital One. For us, a data breach is a reminder that the sensitive information we routinely entrust to organizations has inherent value and can be subject to nefarious attacks. For organizations, it is a reminder of the great responsibility accepted because of the great power received from valuable information. For states across the country, it is a reminder that more needs to be done in the fight for privacy and protection of sensitive information. With the passage of House Bill 4390 (HB 4390), Texas has showed how it plans to address the privacy of personal identifying information.

Signed into law on June 14, 2019, HB 4390 amends Texas’s privacy breach notification law—Texas Business and Commerce Code Chapter 521, Identity Theft Enforcement and Protection Act—by specifying a time frame for when notice of a breach is required and creating a notification requirement to state regulators. Beginning January 1, 2020, if a breach occurs and disclosure is required, the disclosure must be made “without unreasonable delay and in each case not later than the 60th day after the date on which the person determines that the breach occurred.” Previously, the disclosure only needed to be made “as quickly as possible.”

It is important to understand that the 60-day time frame doesn’t create a window for compliance, so organizations should not feel comfortable simply getting disclosures out by the 60th day to comply. Instead, organizations are first responsible to provide disclosure “without unreasonable delay,” which, depending on the circumstances, could be well short of the 60 days. If the circumstances support a reasonable delay approaching 60 days, an organization will then need to ensure that disclosure is provided before the deadline.

Also, beginning January 1, 2020, HB 4390 requires notification to the attorney general for breaches involving at least 250 Texas residents. The notice will need to include:

  1. A detailed description of the breach;
  2. The number of residents affected;
  3. The current and planned mitigation efforts; and
  4. Any law enforcement involvement.

All organizations subject to Texas’s breach notification law should begin reviewing and updating their breach notification policies in preparation for the new rules in 2020.

In addition to the current changes to the Texas privacy breach notification law, HB 4390 signals that Texas is not done addressing privacy with the creation of the Texas Privacy Protection Advisory Council. The purpose of the council will be to study various privacy laws and make recommendations to the Texas legislature on specific changes regarding privacy and protection of sensitive information.

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.

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

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

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Texas Medical Board Holds New Stakeholder Meeting on Proposed Changes to Rule 193.17

Posted By Administration, Thursday, October 10, 2019

texas capitol

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

On October 8, the Texas Medical Board (TMB) held a stakeholder meeting to discuss Rule 193.17—a rule in development that would bring changes to the cosmetic medical delegation rule, known as Rule 193.17. You may recall that the TMB held a similar meeting earlier this year, which we discussed here. In that prior meeting, two versions of possible changes were offered. Ultimately, only a new signage requirement moved forward and was adopted (see here). The more sweeping proposed changes were tabled for additional work and future consideration. This week’s meeting was to solicit feedback on the most recent version of these developmental rules. Representatives from AmSpa attended this meeting as well.

In addition to a number of small changes to the current version of 193.17, these new developmental rules would make large changes in three areas: delegation, supervision and ownership. These developmental rules would change the definition of who is qualified to perform medical spa procedures. The proposed version would allow only licensed or certified health care providers to perform the procedures under supervision; the current version of the rules allows unlicensed persons to perform the procedures. The proposed rules also would necessitate that a physician, or a physician assistant (PA) or advanced practice registered nurse (APRN) under their delegation, to provide onsite supervision of the qualified personnel while procedures are being performed; the current rules require either onsite supervision by the physician, PA or APRN, or offsite physician supervision as long as they are available for emergency consultation and appointment if necessary. As part of the required supervision, the physician will need to cosign procedures performed under supervision within 72 hours; the current rule requires “timely” cosigning of procedures performed by unlicensed people, but does not specify a definite time limit.

The third major area of change is the inclusion of an ownership statement. Two versions of this section have been suggested. The primary version would require that facilities offering these procedures be owned by a Texas licensed physician; the owner, in turn, may employ a medical director to supervise and delegate. This version makes it clear that all physicians delegating and supervising in the facility are responsible for complying with all rules and laws for the supervision and delegation of medical procedures. The alternate proposal would require that any physician who accepts a medical director position first notify the board of the facility location and provide owner information, a list of all people to which procedures can be delegated, and the names and license numbers of the supervising physicians; any changes to this information would need to be updated within 30 days. The supervising physician also would need to provide an alternate supervising physician to step in if they are unavailable.

The TMB stressed that these rules are still in development and do not reflect the final version. It is accepting comments and feedback, and has stated it may have a version ready in the coming weeks for formal proposal. If a final version is proposed, this amendment would then be voted on by the full TMB at its upcoming December meeting. If the TMB approves that version, it will be published in the Texas Register and begin a 30-day public comment period before the amendment becomes official. That would be the quickest timeline for official adoption—it is possible that comments and feedback will require additional time before presentation to the full board. AmSpa will continue to closely monitor these changes and will report developments.

Tags:  Med Spa Law  Med Spa Ownership 

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Join AmSpa at the New York Medical Spa & Aesthetic Boot Camp

Posted By Administration, Wednesday, October 2, 2019

new yorker hotel

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

Starting next Saturday, October 12, AmSpa will host its New York Medical Spa & Aesthetic Boot Camp at The New Yorker Hotel (A Wyndham Hotel). We’re extremely excited for the opportunity to help medical aesthetic professionals in the Big Apple improve their practices, and we’re looking forward to visiting New York once again. There’s still time to register for the event—just click here to sign up.

Here is a quick overview of the program:

Saturday, October 12

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 – 10:00 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.
  • 10:15 – 11:15 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.
  • 11:15 a.m. – 12:15 p.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.
  • 1 – 1:45 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), Toni Lee Roldan-Ortiz (Environ Skincare), and a representative from 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.
  • 1:45 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Renee Coover (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, October 13

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 – 9:45 a.m.: The Long-term Revenue, presented by Bryan Durocher (Durocher Enterprises)—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, Bryan will show you how to build patient loyalty and move your business forward.
  • 10:30 a.m. – 11:30 p.m.: The Medical Spa Success Panel, featuring Alexander L. Blinski, MD, (Plump), Marria Pooya (Greenwich Medical Spa), and Alexa Nicholls Costa, NP, and Alexandra Rogers, NP (LexRx)—This exclusive panel features four of the most successful aesthetics professionals in the Northeast. I will ask them how about the innovative business strategies and techniques they used to rise to the top of the medical aesthetic industry.
  • 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 Alexa Nicholls Costa, NP, and Alexandra Rogers, NP (LexRx)—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 New York Medical Spa & Aesthetic Boot Camp to check out the latest and greatest from the following companies:

We hope you can join us in New York next weekend. This Boot Camp is a tremendous opportunity to get a medical aesthetic business started off on the right foot, and 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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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


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


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


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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