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What Aesthetic Practices Need to Know About Naturopathic Medicine

Posted By Administration, Friday, February 21, 2020

naturopathy

By Courtney P. Cowan, JD, ByrdAdatto

Medical consumers are becoming more and more discerning when it comes to seeking health care. Healthier lifestyles, a growing distrust of pharmaceuticals and an opioid crisis have many seeking treatment outside of traditional medicine. Naturopathic medicine, or naturopathy, is one such alternative. Rather than treating and diagnosing individual symptoms, naturopathy aims to treat the whole patient, often prescribing changes in diet and lifestyle, as well as a wide array of holistic supplements.

Due to a lack of industry standards or overall governing authority of the field, there are potential risks that both naturopath clinicians and consumers should be aware of, beginning with the very title—“naturopath.” Many are unaware of the difference between a traditional naturopath and naturopathic doctor (ND). The two are not interchangeable, and regulations surrounding the two professions vary from state to state. According to the Association of Accredited Naturopathic Medical Colleges (AANMC), a licensed ND is a primary care provider who is trained to diagnose and prescribe, while a traditional naturopath is not.

Confusing the distinction further is that naturopathic medicine is not yet a regulated profession in some states, and thus a traditional naturopath may use the title ND, without having earned that degree. In fact, to receive an ND, one must complete four years of schooling by an accredited institution, complete thousands of hours of supervised clinical training and complete two national board exams. In contrast, traditional naturopaths may receive training from online correspondence or certificate programs ranging from a few months to years. These traditional programs lack standardization or onsite clinical training. Even in states where the profession is regulated, the services that each distinction (traditional or ND) is legally able to provide vary.

It is important to note that while licensed MDs and DOs can practice naturopathic modalities, many NDs are not actually licensed by any state medical or osteopathic board. Moreover, while NDs often use holistic medicine to treat patients, there may be some crossover treatments that fall under the definition of the practice of medicine. For example, prescribing medicine, lasers and intravenous treatments may be used in naturopathic medicine; however, these may qualify as statutory medical procedures that legally should only be performed by MDs, DOs or providers who have had specific training for the procedure. In many states, the “corporate practice of medicine” rule, which prohibits anyone but a physician from practicing what is deemed medical, may also apply.

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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Are Medical Director Agreements Required in MSO Arrangements?

Posted By Administration, Monday, February 17, 2020

mso agreement

By Kita McCray, JD, ByrdAdatto

The purpose of a medical director agreement is to memorialize the responsibilities of a physician, which typically entail supervision and delegation, and address physician compensation. In a management services organization (MSO), the physician who owns the medical entity usually is the physician who is in charge of supervision and delegation. Where a single physician owns, delegates and supervises, he or she would not need a medical director contract with themselves. Moreover, financial terms, including medical director compensation, typically are captured in the management services agreement (MSA) between the MSO and the physician-owned medical entity. Thus, medical director agreements are only necessary when a company is operating in a state that allows non-physician-owned companies to contract with or directly employ physicians, and in MSO arrangements where the supervising physician is different than the physician owner.

To determine whether your company needs a medical director agreement, you should begin by looking to two places:

  1. Your state’s corporate practice of medicine (CPOM) doctrine, if any; and
  2. Any applicable supervision and delegation laws or regulations applicable to physicians.

The CPOM is a doctrine that prohibits an unlicensed individual or non-professional entity from:

  1. Practicing medicine;
  2. Employing or contracting with a physician to practice medicine on its behalf; or 
  3. Interfering with or influencing a physician’s professional judgment or practice of medicine.

This includes both the physician’s health care or medical decisions, and business or management decisions that necessarily implicate the practice of medicine.

In CPOM states—such as California, Texas and New York—the medical entity must be properly owned by a licensed physician. A company owned by a non-physician who employs a physician to render medical services and receives compensation in exchange for providing those services is structured in violation of CPOM. Where the MSO model is used to comply with CPOM prohibitions, a medical director agreement would be unnecessary, unless the physician-owner hires a different physician to supervise the medical entity’s operations.

In non-CPOM states, such as Florida, non-physician-owned companies are allowed to contract with or directly employ physicians, so long as the physician’s professional judgment and practice of medicine are not interfered with. Therefore, a medical director agreement would be necessary to specify the responsibilities and compensation of a physician acting as a medical director. Such responsibilities typically are for treatment plans, supervision and delegation, and they are in accordance with state supervision and delegation laws or regulations that are applicable to physicians.

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

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:  Business and Financials  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Updates on the Texas Botox Arrests

Posted By Administration, Friday, February 14, 2020

handcuffed doctor

By Robert J. Fisher, JD, ByrdAdatto

At the end of 2018, much was written about the Texas Botox arrests that resulted in four different medical spa providers being led away in handcuffs or turning themselves into police. These arrests sent shockwaves through the medical spa community, as it marked an aggressive change in enforcement.

However, as of now, three of the four people arrested are no longer being criminally pursued by the state. Michelle Bogle, the LVN injector, and Paula Springer-Bryant, MD, the medical director supervising Savvy Chic MedSpa, were both “no billed” in March 2019. A “no bill” means that the grand jury did not find sufficient grounds to indict the accused. Additionally, Ricky Delatorre-Aguirre, a medical assistant performing injections for RD Aesthetica MedSpa without any proper physician oversight, had his case dismissed July 2019. The Houston district attorney indicated on the dismissal motion that while there was probable cause, the case could not be proven beyond a reasonable doubt at that time. Melissa Diaz Galvan, a medical assistant who was charged with the unlicensed practice of medicine and is being accused of writing prescriptions to patients on a prescription pad belonging to a physician, was the final person indicted. Her case is still ongoing with the next scheduled court date in February.

Perhaps the dismissals and no-bills described above were due to the extremely technical and nuanced nature of the laws that were being violated, which resulted in the district attorney’s office not being able to clearly translate to the grand jury the violations that occurred. On the other side of the coin, the case against Galvan appears to be more straightforward, as the district attorney can show the exact prescription page(s) she was signing on a physician’s pad.

Regardless, we would caution medical spa operators against letting their guard down and thinking that this is a sign of decreased criminal enforcement. Those who can remember the opening voiceover in the TV show Law & Order know that the justice system is made up of the police who investigate the crime and attorneys who prosecute the offenders. While these specific circumstances resulted in dismissals, it does not mean that the police will stop arresting medical spa personnel. It is critical to maintain compliance to prevent arrest in the first place. Even with a dismissal, the image of being led away in handcuffs from your facility is one that is best avoided. We will continue to monitor and provide updates on the enforcement actions being taken by the Houston police and other law enforcement units across the country.

As a final word of caution, the Texas Botox arrests made headlines because of the criminal allegations. Each of these providers and medical spas likely will have to continue to defend their licenses and ability to practice before the medical board. Although they may not face jail time, their livelihoods may hang in the balance.

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

Robert J. Fisher’s passion for health care traces back to his high school days of shadowing doctors. His passion evolved in college to study as a pre-med major. The last major evolution of Robert’s interest in health care was the transition to an interest in health care law. With this education, a business attorney for a father, and a renowned orthopedic surgeon for a father-in-law, Robert has the pedigree for success as a business and health care attorney at ByrdAdatto.

Tags:  ByrdAdatto  Med Spa Law 

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What Does Your Practice Need to Know About CBD?

Posted By Administration, Monday, February 10, 2020

cbd vial

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

The regulatory status of CBD seems to change yearly, if not monthly. It’s enough to give the public whiplash. CBD, the non-psychoactive ingredient of marijuana or industrial hemp, supposedly treats everything under the sun now. Putting aside any claims of efficacy, what is its regulatory status?

The 2018 Farm Bill removed cannabis with extremely low concentrations of THC from the definition of “marijuana” in the Controlled Substances Act. Marijuana and industrial hemp are cultivated from the same species. Hemp and recreational cannabis are essentially the same plant. Industrial hemp has low concentrations (less than 0.3%) of the psychoactive component THC. The Farm Bill expanded the definition of hemp from stalky cannabis plants with small leaves to any cannabis plant with less than 0.3% THC. Sale of CBD from cannabis that has less than 0.3% THC no longer violates the Controlled Substances Act.

So far, so good. Removing CBD from the Controlled Substances Act explains why we see countless shops selling CBD in every state. But while the Department of Justice and the Drug Enforcement Administration now take the position that CBD is a non-issue, not every government agency agrees.

Amy Abernethy, MD, PhD, principal deputy commissioner of the U.S. Food and Drug Administration (FDA), said, “At present, any CBD food or purported dietary supplement products in interstate commerce is in violation of the FD&C [Food, Drug & Cosmetic] Act.”

The reason: Epidiolex.

You would correct in retorting, “Huh?”

Epidiolex is a CBD product manufactured by GW Pharmaceuticals. It is FDA approved to treat specific types of medication-resistant seizures. Under the FD&C Act, it is illegal to sell a product that contains an active ingredient in an approved drug across state lines. The FDA considers products that contain CBD to be unapproved new drugs that violate the FD&C Act, even if such products claim to be dietary supplements. To the FDA, the same compound cannot be both a drug and a dietary supplement.

In other words, once CBD was approved by the FDA to treat seizures, entities other than GW Pharmaceuticals had no permission to sell it. The FDA treats it as a “counterfeit product,” even if street CBD is indistinguishable chemically from the product distributed by GW Pharmaceuticals.

On one level, it makes sense. If Pfizer spent a decade and $1 billion doing clinical trials on a compound prior to approval, and a mom-and-pop store decided to sell knockoffs that were indistinguishable chemically, the FDA would take action.

So, once Epidiolex was approved by the FDA as a CBD compound to treat seizures, over-the-counter CBD became illegal as a supplement.

This seems confusing. In other words, the compound went from okay to illegal.

There is an FDA-approved fish oil, Vascepa. However, I can still walk down the aisle at Costco and see plenty of over-the-counter fish oil. Plus, there are pharmaceutical-grade vitamins and dietary supplements, such as Carnitine and Niacin. Likewise, if you walk into GNC, you’ll see scores of such supplements.

Trying to think this through from a regulatory standpoint is enough to make your head explode.

Will the FDA take action against stores selling CBD? It’s doubtful, unless individuals are harmed by the product or wild and outrageous claims are made by the seller. On the radio and in magazine ads, the fine print for supplements generally states that such compounds are not intended to diagnose or treat any condition. That would seem to be the bare minimum needed to sell CBD without triggering the FDA’s wrath.

The FDA does not have unlimited resources to make good on its assertion that distributing CBD across state lines as anything other than Epidiolex is illegal. Time will tell.

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

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

Tags:  ByrdAdatto  Med Spa Law 

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What California Medical Spas Need to Know About AB 5

Posted By Administration, Monday, January 27, 2020

practitioner

By Bala Mohan, JD, ByrdAdatto

California Governor Gavin Newsom’s recent signing of Assembly Bill No. 5 (AB 5) could potentially reclassify millions of independent contractors as employees and dramatically reshape the future of workforces in California. This legislation could have far-reaching effects on the medical practice industry.

What is AB 5?

AB 5 codifies, clarifies and grants exemptions to a 2018 California Supreme Court decision referred to as “Dynamex.” Basically, AB 5 and Dynamex make it more difficult for companies to label workers as independent contractors. AB 5 offers the “ABC” test to determine independent contractor status. Under this test, a worker is presumed to be an employee unless all three of the following criteria are met:

  • The worker is free from control and direction in the performance of services;
  • The worker is performing work outside the usual course of the business of the hiring company; and
  • The worker is customarily engaged in an independently established trade, occupation or business.

The AB 5 definition of an independent contractor is much narrower than the previously used standard, called the Borello test, and the ABC test puts the burden on the hiring entity to prove independent contractor status. More information on the AB 5 law and how it may apply to you can be found on the California Labor and Workforce Development Agency website.

Who is Exempt from AB 5?

Dozens of professions won exemptions under this new law, and those that are exempt will use the more lenient Borello test for employee classification questions. Exemptions affecting the medical industry include physicians, dentists, podiatrists and psychologists; other exempt licensed professionals include veterinarians, aestheticians, electrologists, manicurists, barbers and cosmetologists. In addition, in order for the above-mentioned licensees to be subject to the Borello test, the company also must show that the worker:

  • Sets their own rates and hours and processes their own payments;
  • Receives payment directly from the client; and
  • Maintains their own license and book of business.

What Does This Mean for Medical Practices in California?

Medical practices—including surgical practices, medical spas, weight loss centers, IV hydration bars, functional medicine practices, and practices offering other anti-aging or wellness medical services—must look at their staffing model to prevent this misclassification on both a state and federal level. Potential liabilities and fines for misclassification can be costly. Companies employing or contracting with personnel should make sure they understand who will qualify as an independent contractor under AB 5.

AmSpa members receive a complimentary 20-minute Introductory Compliance Assessment with a ByrdAdatto attorney. Click here to learn how to join AmSpa 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:  Business and Financials  ByrdAdatto  Med Spa Law 

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One Week Until The Medical Spa Show in Las Vegas

Posted By Administration, Friday, January 24, 2020

medical spa show

The Medical Spa Show is only a week away, and there’s still time to make your plans to join the more than 1,000 people who have already registered. It takes place from January 31 – February 2, 2020—with Thursday Pre-show Education on January 30—at the Aria Hotel & Casino in Las Vegas. Regular registration ends on Tuesday, January 28, so if you’re considering attending, make sure to complete your registration by then—the cost for onsite registration is higher than if you register in advance.

The Medical Spa Show features six concurrent tracks of education—including two tracks of sponsored education—and an Expo Hall featuring more than 120 exhibitors demonstrating the medical aesthetic industry’s newest and most exciting products and services. Of course, it also features the industry’s best parties, and it’s a great place to network with fellow medical aesthetic professionals and industry leaders. There's something at the show that will help each member of your team, so bring them all to maximize the show's benefits!

What’s more, AmSpa Members can attend Thursday night’s Members Meeting, sponsored by Allergan—featuring influential, inspirational podcast superstar Cathy Heller—and everyone can come to the Opening Night Party on Friday night. Finally, after the regular show program ends on Sunday, AmSpa will present Live Cadaver Training: Facial Anatomy Course, taught by Jonathan M. Sykes, MD, for an additional fee for Medical Spa Show attendees who wish to learn more about what their injectables are actually doing. (Click here to learn more.)

Be sure to register today to reserve your space in the sessions you want to attend—several sessions are already at capacity, and others are nearing it, so don’t wait! Click here to begin the registration process right now!

We at AmSpa hope to see you in Las Vegas next weekend! It promises to be the biggest, best Medical Spa Show yet!

Tags:  Business and Financials  Med Spa Law  Med Spa Trends  The Medical Spa Show 2020 

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How to Choose a Business Entity for Your Medical Spa

Posted By Administration, Monday, January 20, 2020

business entities

By Michael S. Byrd, JD, Partner, ByrdAdatto

Choosing an entity for your business can be overwhelming. Clients often seek ByrdAdatto’s advice, confused by the choices and the process. From partnerships, sole proprietorships and corporations to limited liability companies (LLCs), each entity offers advantages and disadvantages, depending on your unique business model.

Choosing an entity should be informed by your current business strategy, in conjunction with your vision for the company for the future. Among other things, the choice of entity can affect tax structure, capital raising, initial public offerings, mergers and acquisitions, and distribution structure.

While forming an entity without strategic thought and input stems could potentially cause you to choose the wrong structure, tactical mistakes often are made in the formation process. Many clients don’t realize that there actually are two separate filings to consider: first with the state, and second with the U.S. Internal Revenue Service (IRS).

Filing With the State

State filings are nuanced and often dependent on options available in a specific state. Entities owned by a professional requiring licensing—by the state or other jurisdiction—may have more limited options. For example, in California, a medical practice must file as a corporation, and may be required to file additional documents with the state’s medical board. Otherwise, professional entity choices can include:

  • Professional corporation (PC);
  • Professional medical corporation (PMC);
  • Service corporation (SC);
  • Professional association (PA);
  • Professional limited liability company (PLLC);
  • Limited liability partnership (LLP); and
  • Unincorporated sole proprietorship.

Overall, LLCs—and their professional counterparts, PLLCs—are the most commonly formed entities. An LLC is flexible and can be customized to different business models, while also leaving open a menu of tax options. In circling back to the strategy and vision considerations, the LLC’s flexibility tends to be a great starting point when the vision for the business is uncertain.

The corporation as an entity choice has its place in more complicated businesses that raise outside funding from private equity or have a plan to become a publicly traded company.

Filing With the IRS

We stress to clients that an entity choice at the state level dictates your choices with the IRS, and thus how you will be taxed. For example, filing as a corporation limits your choices with the IRS to either a C-corp or an S-corp. If you form a partnership (limited, general or limited liability), your choices with the IRS will be limited to a partnership. The popularity of the LLC for tax election with the IRS again rests with its flexibility. An LLC can choose to be taxed as a corporation (C-corp or S-corp), a partnership (as long as there is more than one owner) or a disregarded entity (if there is one owner).

There are many pitfalls to avoid and variables to consider in choosing the right corporate entity for your business. At ByrdAdatto, we advocate simplification. Much like reducing a fraction to its lowest common denominator, we aim to provide simple solutions on complicated topics.

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

With his background as both a litigator and transactional attorney, Michael Byrd brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2018) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016, 2017, 2018). He routinely lectures at continuing medical education seminars on the various business and legal issues that medical professionals face.

Tags:  Business and Financials  ByrdAdatto  Med Spa Law 

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Hyaluronic Injection Pens: What You Need to Know

Posted By Administration, Wednesday, January 15, 2020

hyaluronic acid

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

 In the past several months, you may have noticed an explosion of ads, social media posts, articles, videos and training events talking about an “incredible” new injection device that can place hyaluronic acid filler in the skin without using a needle. These devices are often marketed as “non-invasive” or “non-medical,” using names such as “hyaluron pen” or “hyaluronic acid atomizer.”

However, make no mistake—just because they do not have needles does not mean these products are not medical devices or that they can be used without risk. On September 13, 2019, the Canadian Department of Health issued a warning regarding these devices. It stated these injectors pose health risks and are not authorized for sale in Canada. In the U.S., while no state has publicly commented on these devices yet, “administering medication,” no matter the method used, is part of the definition of each state’s “practice of medicine.” Therefore, these needle-free injection devices should be treated the same as traditional syringes. People wanting to perform these treatments still need to have the same type of professional license they would need to inject using a needle and syringe, and they will still need to work under the supervision of a physician or another appropriate professional.

No Needle, No Problem?

Needle-free injection devices generally are used to deliver vaccines and medications either intramuscularly or subcutaneously, similar to a traditional needle and syringe. They work by creating a very narrow high-pressure jet of medication that is able to penetrate the skin; the jet is generated using gas or spring pressure to force the medicine through a small opening in a disposable vial. The benefits claimed include lower chances of cross-contamination, reduced needle-stick injuries, and less sharp medical waste. This makes these devices particularly well suited for inoculation campaigns, clinics and home self-administration of insulin or other medication.

Medical devices and substances may not be marketed in the United States without obtaining U.S. Food and Drug Administration (FDA) approval. FDA approved or classified devices may be marketed only for their approved use. For FDA registration, needle-free or jet devices fall into three broad groups:

  1. General-purpose injection devices meant to be used for injecting drugs that work in needle-free systems;
  2. Devices meant for a certain class of drugs, such as insulin, or use with a specific manufacturer’s specific product line—both of these groups are considered class II medical devices; and
  3. Devices intended to be marketed with a specific product, either labeled for use or sold together, and therefore treated as a combination device.

The first and second group of injectors are regulated using the premarket notification process under the 510(k) provision. These premarket notifications are granted when a new device is substantially similar to an existing approved device, and they allow the manufacturer to begin marketing the product while it complies with the more lengthy registration and approval process. In order to be cleared in this process, at least one drug or injectable substance must already be approved for this method of injection.

A number of needle-free and jet injectors have these filed premarket notifications with FDA; however, none of the “hyaluronic pens” currently on the market appear to correspond with any of these premarket notifications or be from manufacturers who have applied for one. Additionally, FDA has approved a number of hyaluronic acid-based fillers for injection using the traditional needle and syringe method. Thus far, no hyaluronic acid fillers have been approved for use in needle-free injectors. So, any pen injector under the premarket category would need to be compatible with an approved substance other than hyaluronic acid, and, once approved, could not be marketed for use with hyaluronic acid-based fillers.

The majority of the hyaluronic pens currently listed online are packaged with a supply of hyaluronic acid, which would most likely place them in the third category. Devices in this category are considered combination products and can be marketed for that specific use and product after approval. It does not appear that any of the currently marketed “hyaluronic pens” have any FDA approval for their use as Class II devices meant for general injections, and certainly not specifically for using hyaluronic acid.

On the Up-and-up

While no needle-free devices have been approved for hyaluronic acid, several needle-free injection devices have received FDA approval for use with specific drugs, which is something a properly marketed hyaluronic filler device would need to receive. For example, in 2014, a needle-free injector manufactured by PharmaJet and Seqirus Pty. Ltd.—manufacturer of the influenza vaccine Afluria—received approval to administer the Afluria vaccine using the PharmaJet Stratis injector for patients from 18 to 64 years old. FDA made clear, however, that it still recommends sterile needles and syringes for other vaccines and for patients younger than 18 and older than 64.

FDA approvals for both injectable drugs and injection devices are narrow and specific. In the above example, a pediatric office would be in violation if it advertised this service to its patients, since using it on those under 18 is not approved.

Many of these devices are marketed for at-home personal use and can be purchased through several online retailers. Some issues with the marketing of these devices are discussed above, but there are other issues for those who want to use these devices at home.

Safe and Sound

Surprisingly, there are relatively few legal issues for those wanting to treat themselves. While hyaluronic pens can’t legally be sold, they can be possessed for personal or non-medical use. Furthermore, people are generally free to do things for themselves that would normally require a professional license if performed by another—you can cut your own hair without a barber’s license, you can write your own contracts without a law license, and you can treat your fever without being a doctor. Similarly, someone can possess a jet injector for their personal use, as well as possess syringes and scalpels if they so choose. It is worth noting, however, that in some states, possessing prescription drugs and substances—such as injectable hyaluronic acid—without a prescription is prohibited. And offering to perform these treatments on others is considered the practice of medicine without a license.

From a practical standpoint, people should think carefully before choosing to perform medical procedures on themselves. The jet injectors being sold are not designed for this use—they appear to be rebranded and repurposed injectors that are not approved in the U.S. The hyaluronic acid fillers sold with them and available online also are not approved for injection into humans and often are of unknown sterility, safety or quality.

Additionally, much like the concept of “cutting hair,” the concept of using the pen injector sounds very simple. However, just as successfully giving yourself a haircut is far more complex than it seems, performing injections on yourself more complicated than it might appear. Those wanting to perform these treatments should first discuss the risks and potential complications—such as infection, contamination or vascular occlusion—with their physician.

Professional Considerations

Medical aesthetics professionals may be interested in bringing needle-free devices into their medical spa practice. This creates its own set of questions—namely, can you? And should you? Licensed health care professionals can be subject to professional penalties and discipline on their license if they are found to be using non-FDA-approved medication or devices. However, physicians generally are able to use otherwise-approved devices and drugs in ways that are not yet approved by the FDA. This is commonly known as “off-label use,” and it is the source of a great deal of innovation and advancement in the medical field. However, physicians are not allowed to advertise and promote off-label uses. Additionally, using unapproved devices in an unapproved way can create standard-of-care and liability issues for the practitioner if the patient experiences an adverse outcome.

So, while it would not be advisable for a nurse or physician to purchase one of these unapproved, illegally marketed devices off eBay, for example, a physician could take an FDA-approved needle-free injector and repurpose it for injecting FDA-approved fillers, so long as they did not market or advertise this practice. The question then becomes—does it make sense to do this? Do such devices bring additional capabilities over the current syringe-and-needle techniques?

While many of the approved devices allow for the dosage per “firing” to be metered, it does not appear that the placement of the medication can be done as precisely as using a syringe and needle—there is no way to ensure that the filler is injected in the precise location or depth, or in the amount desired. According to studies conducted by jet injector manufacturers, the amount of the drug that is actually delivered and the precise location of delivery can vary from injection to injection. The depth and penetration also can be influenced by tissue density, the angle of the injector to the skin, and the pressure applied against the skin prior to firing.

While these variables can be within acceptable limits for administering vaccines and medicine, would they be acceptable for cosmetic treatments on someone’s lips or face? Additionally, in the FDA’s Afluria/PharmaJet announcement on August 15, 2014, both the study performed for the approval and two prior needle-free injector studies (Jackson et. al. Vaccine 2001, Simon et. al. Vaccine 2011) found that needle-free injections had a higher rate of pain, redness and swelling at the injection site than those who received traditional hypodermic injections. Newer devices may remedy some of these issues, but any licensed practitioner should carefully consider the pros and cons before integrating this off-label use into their practice.

Taking Your Chances

The current crop of “hyaluronic pen” devices that are unscrupulously and illegally being marketed to the public create many issues, even beyond their lack of FDA approval. The public should be extremely wary about using these devices, and under no circumstances should anyone perform this treatment—or any other cosmetic injectable—unless they hold an appropriate health care professional license or are working under the supervision of a physician. Licensed health care professionals should educate their patients about the risks of these at-home, unapproved products and should always carefully consider the benefits of adding a new or novel treatment to their practice.

Tags:  Med Spa Law  Med Spa Trends 

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How to Conduct a Practice Assessment for Your Medical Spa

Posted By Administration, Friday, January 10, 2020

assessment

By Jay Reyero, JD, Partner, ByrdAdatto

We are all familiar with New Year’s resolutions. At the end of each year, we conduct a self-assessment and set goals for ourselves heading into the new year. Slowly—or in some cases, on the first day—we drift away from those goals only to repeat the cycle at the end of the year and the beginning of the next. Similarly, businesses can find themselves drifting away from goals or compliance standards over the course of the year. In preparing for a new year, medical providers should conduct a self-assessment in the form of a practice assessment.

Gathering all the documentation and information you wish to analyze is the starting point of any practice assessment. In setting the scope of the assessment, you should start with documentation from the following four areas:

  1. Corporate documents;
  2. Financials;
  3. Staffing; and 
  4. Policies and Procedures.

Once these are gathered, you can begin the assessment by identifying whether anything is missing or conflicts with how things are or are believed to be with your business. The hope, though, is that you confirm everything remains aligned.

It also is important to remember that a practice assessment should include analysis by each member of your advisory team. In addition to legal counsel, you should include your CPA, tax advisor and financial advisor for their respective perspectives. Once again, all aspects of your business should be aligned to prevent any issues.

Finally, like New Year’s resolutions, a practice assessment should be an annual tradition. Compliance is not static, and health care is constantly changing, so you need to ensure your business doesn’t fall out of compliance. Unlike the New Year’s resolutions, hopefully your compliance can last longer than a day.

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

Jay Reyero, JD, is a partner at the business, health care, 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. His 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:  Business and Financials  ByrdAdatto  Med Spa Law 

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Is It Legal to Practice as a Medical Aesthetician?

Posted By Administration, Monday, January 6, 2020

aesthetician

By Sam Pondrom, JD, Associate, ByrdAdatto

Fake or Real: I am licensed as a medical aesthetician.

Fake! Aestheticians must practice within the state-promulgated scope of practice and only use titles authorized by their license.

To determine their scope of practice, an aesthetician should look to three places:

  1. The state laws defining aestheticians’ scopes of practice;
  2. Any rulings or opinions issued by the aesthetician’s licensing board addressing scope of practice or ability to accept delegation from medical practitioners; and
  3. As it pertains to medical services, the supervision and delegation rules applicable to physicians.

The confusion about the existence of medical aestheticians arises from situations where state-licensed aestheticians have obtained additional education, training, certification and experience, or “competence.” These aestheticians who have sought out and acquired additional competence often believe that they have expanded their scope of practice, meaning they may:

  • Perform tasks or accept delegated tasks normally outside of their scope of practice; and/or
  • Perform delegated tasks with less supervision than a standard aesthetician.

However, this is not necessarily true.

The most important thing to understand about aestheticians is that they are creatures of state law. They must obtain a license from the state(s) in which they practice, typically from the state board of cosmetology. These state cosmetology boards have promulgated regulations and rules that determine licensure requirements, scopes of practice and approved titles. The aesthetician license issued by a state board only allows aestheticians to perform work within the prescribed scope of practice and use the approved title. By designating oneself a medical aesthetician, an aesthetician can be viewed as unilaterally expanding their scope of practice or adopting a new title—or both. These actions may subject an aesthetician to disciplinary action from the cosmetology board.

Complicating this further is that state cosmetology boards have no jurisdiction over the practice of medicine. By adding the term “medical,” aestheticians create another issue for themselves with state medical boards. Generally, when state law defines the practice of medicine with the goal of reserving that practice to appropriately licensed persons such as physicians, they include language protecting the use of titles and descriptors that would lead the general public to believe a person is licensed to practice medicine. Thus, if an aesthetician describes themselves as a medical aesthetician or expands their scope of practice to include services considered the practice of medicine—or both—they may be violating their state’s prohibition on practicing medicine without a license.

Often, we find aestheticians have spent their own time and money on courses that purport to train them to be medical aestheticians, but it is important to consider the source of the training. A quick Google search for “medical aesthetician course” returns many results. But if you look at the course information provided by a company offering medical esthetician classes, you almost always will find some variation of a disclaimer that says aestheticians must look to the law of the state that licensed them for the rules and regulations on their practice.  This means that regardless of what the coursework purports to teach (e.g. lasers, injectables, dermabrasion, etc.), you can only perform the functions allowed by your state’s laws.

We do want to clarify that the point of this post is not to discourage aestheticians—or any licensees—from obtaining education, training and certification to expand their knowledge base. Rather, aestheticians must take the time to fully understand their scope of practice and ability to accept delegated medical services before investing time and money on medical aesthetician classes. Moreover, aestheticians must understand that by advertising themselves as medical aestheticians, they can expose themselves to some level of additional risk.

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

Tags:  ByrdAdatto  Med Spa Law 

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