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Medspa Slammed with Class Action Lawsuit for Violating TCPA

Posted By Administration, Thursday, February 14, 2019

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

Ever heard of TCPA? 

Most people haven’t. 

It stands for Telephone Consumer Protection Act. And it’s the second most frequent federal lawsuit after employment law claims. And now a medspa is on the receiving end

Simply put, it’s a cash cow for plaintiff’s attorneys. And why not? As Willie Sutton once opined… he robbed banks because that’s where the money was. 

What is it and what triggers it?

In 2019, TCPA is mostly triggered by SMS text message marketing. The business send offers to its prospects by text message. Text messages are generally opened and read. It’s effective.

SMS texting implemented by automated systems is regulated by the Telephone Consumer Protection Act of 1991 (TCPA). TCPA is enforced by the FCC. The FCC updated its TCPA regulations in July of 2015. And there’s a recent appellate court ruling which considered whether the FCC over-reached. That ruling created more questions than answers. The litigation machine roars on. 

Initially, TCPA was designed to prevent dinner being interrupted by pre-recorded junk marketing calls to landlines. That was in 1991. When we had land lines and actually ate dinner together. Today, TCPA mostly tackles text messages. 

The statutory damages for violating TCPA is $500 per text or actual damages, whichever is greater. The statutory damages are up to $1,500 per text for willful or knowing violations. 
It doesn’t take much for this number to get large quickly. 1,000 x $500 = $500,000.

Because the number can get large quickly, class action lawsuits in this domain are enticing to attorneys, even when a business has done everything right. There is no cap on aggregate statutory damages. Multi-million dollar settlements are not uncommon. 

In Kolinek v. Walgreen, Walgreens settled a class action suit for $11 million. What horrible thing did Walgreens do? A consumer provided his mobile number to Walgreens when he picked up a prescription. The pharmacist allegedly stated the number would only be used to verify his identity for future refills. Walgreens then sent messages reminding the consumer to pick up his refills. (Here, the number was not actually used to “verify his identity”; it was just a helpful reminder about refills.) The consumer filed a TCPA class action lawsuit. Multi-million dollar settlement. By the way, each consumer received about $20. The lawyers received millions.

How does a business prevent such mischief? If the text message is advertising or marketing, the business must obtain express prior written consent from each consumer who will receive a text. The consumer cannot be charged for the text. There’s a laundry list of items that must be included in a consumer’s written consent to be TCPA compliant. And the burden is on the business to obtain this consent. Getting this consent is like getting HIPAA consent for every consumer – yet again.

We’re sure a business that sells TCPA services will tell its clients not to worry. But, are they willing to indemnify the client for potential multi-million dollar judgment? Most errors and omissions or general business liability policies do not cover TCPA claims or they explicitly exclude TCPA claims. Medical malpractice insurance claims do not cover TCPA claims. 

At least with medical malpractice, a plaintiff needs to allege an injury. The doctor is typically covered with medical malpractice insurance. And many states cap damages. 

With TCPA, the sky is the limit. The mistake can be innocuous. And insurance is generally not available to ease the sting.

Still, it IS possible to promote robust SMS text message marketing campaigns and comply with TCPA. The time to get this right is before there’s a problem. 

Tags:  Business and Financials  Med Spa Law  Med Spa Ownership 

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Should Your Med Spa Offer Aesthetician Services?

Posted By Administration, Tuesday, January 29, 2019

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

While medical spa services command higher prices than traditional spa treatments, medical spa owners and operators shouldn’t overlook aesthetician services. These can be lucrative opportunities for added services for your patients, increasing both retention and profitability of your med spa practice.

What Can Aestheticians Do For You?

According to the American Med Spa Association’s 2017 Medical Spa State of the Industry Report, aesthetician services were one of the leading revenue-generators in medical spas. These treatments can include facials, aesthetician-grade chemical peels, and waxing, to name a few. This category also includes Hydrafacials, which is one of the fastest-growing treatments in medical spas regardless of practitioner type.

Some Caveats

In many states, treatments such as microneedling and dermaplaning are considered to be the practice of medicine. Because of this, they should only be done by a licensed medical professional. However, there are some situations in which a person holding an aesthetician license may perform these procedures.


Microblading is also a treatment that individuals holding aesthetician licenses perform in many states. State laws can vary regarding this procedure, but it is often categorized as permanent makeup and, with some additional training, these practitioners can often offer this service in medical spas.

Contact an attorney familiar with medical aesthetic laws in your state for more information on microneedling, dermaplaning, or microblading. (AmSpa members can take advantage of their annual complimentary compliance consult with the law firm of ByrdAdatto, or check their medical aesthetic state legal summary.)

Legal Requirements
To add these aesthetician services to your medical spa, first be sure that the practitioners you hire are properly licensed to perform these treatments. This should be of paramount importance for all of your service providers, whether offering beauty services or medical treatments. In-depth training and proper licensure ensures that your patients are getting the best possible services and results, and also protects your staff and business against fines and other punishments from regulatory agencies. Your business will also need to obtain an establishment license for these procedures, and that license must be displayed in your facility during business hours. Additionally, be sure to double check with your insurance-provider to make sure you are covered to offer these additional treatments. Assuming that your other business housekeeping is in order (LLC, tax ID, etc.), you should now be set to offer another tier of services to your clients.

For more information on medical spa legal best-practices attend The Medical Spa Show 2019 or one of AmSpa’s Medical Spa & Aesthetic Boot Camps.

Tags:  Med Spa Law  Med Spa Trends  The Medical Spa Show 2019 

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New York’s Laser Hair Removal Problem

Posted By Administration, Tuesday, January 22, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

Laser hair removal (LHR) is one of the most commonly performed non-invasive aesthetic procedures in the U.S., and almost everywhere, it is regulated the same. Most states view LHR as a medical procedure that requires proper training and physician supervision. In a few states—including Georgia, Texas and Massachusetts—non-physicians may perform LHR without physician supervision, provided it is within their scope of practice and they meet certain requirements. In Georgia, for example, a non-physician can apply for and obtain a Cosmetic Laser Practitioner’s license, provided they complete certain courses—and pay a $200 fee, of course.

But in New York state, LHR is entirely unregulated, and thanks to a article titled “Marked” by Elizabeth Roy Stanton that was published by Medium in December 2018, this fact is receiving national attention. “Marked” is a harrowing account of how Stanton’s decision to undergo LHR at a salon in Scarsdale, N.Y., resulted in physical scarring. (AmSpa and ByrdAdatto aided Stanton in preparing the article.)

“At some point in the past, the medical board declared that lasers, when used for hair removal only, are not the practice of medicine, so they don’t oversee who does it,” said Patrick O’Brien, legal coordinator for AmSpa. “There’s no other regulatory body, so laser hair removal is unregulated in New York. Essentially, anybody can go buy a laser, open up a shop, and start doing laser hair removal.”

This relates only to laser hair removal—other uses of lasers in aesthetics are considered to be medical in nature and therefore are regulated by the state medical board and require physician supervision. In the years since the board declared that it did not consider laser hair removal to be medical, the state has attempted to close this loophole, but its efforts have as yet been unsuccessful.

“[The state legislature] tried for several years to pass some kind of licensing regulation,” O’Brien said. “They had a bill last year, but I believe it didn’t gain any traction from medical groups because the bill would have allowed non-medical persons to perform [LHR]. I believe the one before allowed you to become licensed, just like you’d become licensed for doing tattoos or becoming an esthetician.”

On January 18, 2019, a new bill that would create a LHR licensure procedure was filed in New York. This would create a situation similar to Texas’ LHR law, which allows licensed individuals to operate largely independently, though they are required to submit to periodic oversight by a physician. However, it remains to be seen if it will be passed into law.

“It seems like the trend is to create a separate license,” O’Brien said. “Most states treat it as a medical procedure, and so a doctor has to supervise it, but many are seeing that it is relatively safe and that people, with training and being properly overseen, can do it. I think you’ll see states move to open it up to more people, just because it’s so common.”

Stay tuned to AmSpa for more details as this story develops. And if you’d like to learn about the laser laws in your state, join AmSpa or consult an experienced health care attorney.

Tags:  Med Spa Law 

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Off-label Considerations for Mid-level Practitioners

Posted By Administration, Friday, January 18, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

We’ve discussed the issues and legalities with prescribing drugs for uses other than what the FDA originally approved them for here. Known as “off-label use” the practice is often routine and generally acceptable as the FDA does not control the practice of medicine.  Most of the current discussion looks at off-label use from the perspective of licensed physicians.  Generally, physicians are permitted to prescribe drugs for off-label purposes without restriction as part of their license to practice medicine.  However, this isn’t necessarily the case for mid-level prescribers such as physician assistants (PA) and nurse practitioners (NP). Below we’ll discuss some of the common limitations and concerns mid-levels face in prescribing off-label.

One of the least common types of off-label restrictions are placed on particular drugs or for particular purposes.  A few states have adopted specific prohibitions against off-label uses for certain classes of drug or for treatment of specific conditions.  These tend to be passed in relation to controversial topics or as a result of a publicized scandal. As an example, Mississippi prohibits all off-label uses for drugs prescribed for the sole treatment of weight loss.  And in North Carolina prescribers working through telemedicine are prohibited from prescribing medications for the purpose of inducing an abortion and this extends to any drug with a known off-label use as well.  

Far more common are discretionary restrictions that a supervising physician may place on a mid-level practitioner. In most states, PAs and NPs derive their prescriptive authority from a collaborating or supervising physician.  This is normally embodied in a mutually written agreement between the physician and mid-level, sometimes requiring board approval.  These are known by various terms such as “practice guidelines” or “supervision agreements”.  These agreements typically outline the procedures and scope of practices that the mid-level is able to perform.  Where these agreements define the scope of the mid-levels prescription authority it will include the types or classes of drugs prescribe and the situations and conditions when they can prescribe them.  So the ability of PAs and NPs to prescribe off-label in these states is largely dependent on if they are authorized by their physician.  This is the case in North Carolina where a PA’s prescriptive authority is governed by their written supervisory agreement with a physician.  They have no blanket restrictions on off-label uses but a supervising physician could restrict their PA to only prescribing for on-label uses in the practice agreement.   

Most states do not have explicit prohibitions on off-label prescribing by mid-level licensees.  Instead, they may have more general rules on mid-level prescribing that may indirectly impact their ability to prescribe off-label.  These more general rules usually take the form of a Formulary or a restriction as to the standard of care. A formulary is a list of included or excluded drugs that are within the mid-levels prescriptive authority. They are usually collectively developed and maintained by the medical, nursing or pharmacy boards.  Unless each board maintains their own.  For instance, Oklahoma maintains separate formularies for both PAs and NPs.  Each formulary includes a list of drugs the licensees are prohibited from prescribing on their own and the PA also lists classes of drugs that are permitted.  It is in these formularies where some off-label uses for certain drugs may be prohibited directly or indirectly by excluding entirely a class of drugs and not accounting for alternative uses. 

Restrictions on prescribing under “standards of care” are typically found in the statute that grants the prescribing rights to the PA or NP.  The prescription is usually worded to allow prescribing for approved uses unless certain requirements can be met.  Usually, the requirements are that the off-label use is supported by studies or peer-reviewed and is included in the current standard of care for that ailment.  For instance in Pennsylvania  the formulary for PAs allows them to prescribe for a purpose other than what the FDA has listed as indications only if two requirements are met:  1)the supervising physician must authorize the particular off-label use and 2) the use must be supported by peer-reviewed literature from a “recognized body of knowledge”. So PAs in Pennsylvania would be able to prescribe off-label generally if their supervising physician approves it and if the use is already tested and supported by research.  A similar “standard of practice” prescribing restriction can be found in for NPs in Texas.  The Texas Board of Nursing’s administrative code limits NPs to ordering and prescribing medication only for FDA approved uses unless the use is part of an official trial or review board or if the use is both supported by evidence-based research and within the current standard of care for treatment of that particular condition.  While those carve-outs will allow Texas APRNs to prescribe medications for many off-label situations it limits them to only those mainstream off-label uses.  NPs in Alabama have similar requirements to only prescribe off-label if it is part of the current standard of care, supported by evidence-based research, and approved by the collaborating physician. Oregon has a more lax form of this “standard of care” restriction. NPs in Oregon have fully independent prescriptive practice; they don’t have to collaborate separately with a physician.  Oregon NPs are specifically permitted to prescribe for off-label uses but only so long as there are appropriate indications and documentation for those uses.

Restrictions like these can have substantial restrictions on PAs and NPs practicing in medical spas and other similar settings.  Many of the more innovative procedures offered in medical spas do not necessarily have an FDA approved indication and may be too new or too niche to be backed up by the required peer-reviewed studies or research.  Mid-level practitioners who practice in medical spas need to be sure that their state doesn’t have any explicit restrictions on the drugs or the uses that they plan to practice within the medical spa.  But in addition to that, they will want to ensure that they have sufficient documentation and research on file to support these off-label uses as being part of the “standard of care”. 

If you are a physician assistant or nurse practitioner in the aesthetic medical field and are interested in learning about new procedures and legal issues surrounding medical spas you should consider attending the Medical Spa Show taking place in Las Vegas, NV, February, 8-10, 2019.

Tags:  Med Spa Law 

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Blow Struck to Non-Solicitation Agreements in California

Posted By Aly Boeckh, Friday, January 11, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

Generally, California prohibits the enforcement of most employee non-compete clauses with few exceptions. An appeals court decision this past November saw a commonly used and previously accepted non-solicitation restriction caste into doubt in California. The case known as AMN Healthcare, Inc. v. Aya Healthcare Services, Inc. involves former travel nurse recruiters for AMN, a travel nursing placement agency who went to work for Aya a competing travel nursing agency. Travel nursing agencies seek to recruit and place nurses on temporary work assignments throughout the country.

The defendant nurse recruiters had signed a confidentiality and nondisclosure agreement as a condition of employment with AMN. The AMN confidentiality and nondisclosure agreement contained fairly typical restrictions whereby the employee promised to keep company trade secrets secure and confidential. However, it also included what is commonly known as an “anti-solicitation” clause which prohibited former employees for a period of one year or eighteen months after leaving the company from contacting current employees for the purpose of directly or indirectly inducing or causing them to also leave. As a small quirk in this case, travel nurses are considered employees of the agency when they are placed on assignment but may otherwise be customers of the agency. This anti-solicitation clause would seem to be a prudent safe guard for an employment agency to stop former employees from stealing away your pool of potential employees.

Which is unsurprisingly why AMN sued the former recruiters when they recruited away some of AMN’s travel nurses to work for Aya. This, AMN claimed, was in violation of the anti-solicitation clause of the non-disclosure agreement they had previously signed and agreed to. However the trial court sided with the defendants, Aya Healthcare Services Inc. and the former recruiters, and found the restrictions that AMN was seeking to enforce were void as a matter of public policy. And on November 1, 2018 the 4th District Court of Appeals if California upheld that judgement of the lower court. 

To understand why AMN lost we’ll need to look at some peculiarities of California labor law. California strictly prohibits employee non-compete agreements with few exceptions as embodied in the Business and Professions Code section 16600.  In brief, section 16600 makes any contract that restrains someone from engaging in a lawful profession, trade, or business void and unenforceable.  There are a few exceptions to this rule that aren’t applicable in this case such as allowing owners, partners, and shareholders to be restricted by non-compete clauses when they sell a business. However, and this would seem to be a critical exception in this case, the statute does allow for protection of a company’s trade secrets.  For an employment agency trade secrets include the company’s applicant/customer lists and the statute allows for protections of these lists for one year following termination of the former employee.

It would seem that AMN should be able to enforce their non-disclosure agreement using the trade secrets exception. So why did the case not go in their favor? The devil is, not surprisingly, in the details: travel nurses would apply for employment with an agency and if they were selected for job placement would work as employees of that placement agency (here either AMN or Aya). The nurses, to improve their chances of placement might and often did apply with multiple agencies.  So in the case at hand each of the AMN travel nurses that had been recruited to Aya were already registered with Aya, in some cases years in advance of them leaving AMN.  Because of this the court ruled that the identities and contact information of these employees couldn’t be claimed as a trade secret by AMN since, practically speaking, there was nothing secret about it.  Since there was no trade secret exception the court found that the non-solicitation clause was an “unlawful restraint on trade” under 16600 because it sought to prevent the defendants from engaging in their profession as travel nurse recruiters. While the ruling in this case is very fact specific any California employers will want to carefully review their own non-disclosure agreements in light of this Appeals Court ruling. 

If you have questions or concerns on your own employment issues you might consider using one of your AmSpa member benefits which includes an annual legal consultation with the law firm ByrdAdatto.

Tags:  Med Spa Law 

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New California Bill Requires Secure Prescription Pads

Posted By Aly Boeckh, Monday, January 7, 2019

By James M. Stanford, JD, Partner, ByrdAdatto

In 2018, California made several changes to try to curb unauthorized access to controlled substances as part of a national trend in combating opioid abuse. One of the major changes went into effect this past October, when it became mandatory for medical professionals who write prescriptions to first run a search of the patient on the CURES system before issuing a prescription. CURES is the name of California’s prescription monitoring program, a statewide database that documents all prescriptions issued to a person. CURES allows prescribers to check that they aren’t prescribing conflicting drugs or duplicating prescriptions the patient may have received from a different prescriber.

Another major change takes effect January 1, 2019. In its continuing efforts to make the prescribing process more secure and accurate, California will require paper prescriptions be issued only on specially approved prescription pads with certain security features (“Secured Pads”). The mandatory security features for Secured Pads were enacted in the bill known as AB 1753. Among the features are a number of identifying marks including a watermark, lot number, printer identification number, unique serial number, and latent repeating “void” pattern that becomes visible on photocopies. The Secure Pads can be obtained from any printer who has been approved by the California Department of Justice as having implemented the necessary security features. The Attorney General’s website maintains a list of approved printers where the Secured Pads can be ordered; however, ordering them prior to AB 1753 taking effect would have been difficult as the list did not appear until 1/1/19.

As AB 1753 was passed in mid-September, there may be other issues with enacting the secure printing requirements in time. In fact the California Medical Board just released a memo on Friday, December 28th alerting physicians to the new requirements. Questions about approved printers or the Secured Pad program can be emailed to SecurityPrinter@doj.ca.gov.

As the California Medical Board memo notes, there is no transition period phasing in the use of the Secured Pads, meaning pharmacists are only permitted to accept Secure Pads beginning January 1, 2019. In the event a prescriber is unable to obtain Secure Pads immediately, there are a few alternatives. Given that the law only affects paper prescriptions, prescribers may continue with existing electronic prescriptions. If electronic prescriptions are not a viable option, a prescriber may call the pharmacy and make a verbal prescription for Schedule III – V drugs. If the prescription is for a terminally ill patient, the prescription can be made on a noncompliant prescription pad under the Section 11159.2 exemption. In certain emergency situations, a prescription can be issued on a noncompliant prescription pad as long as a prescription from a Secured Pad is issued within 7 days to cure the noncompliance. The California Medical Board also maintains a page of their website with additional information and procedures to follow when reporting a lost or stolen prescription pad.

If you are an AmSpa member and you have any questions about California’s new prescription pad requirements or your medical practice’s compliance in general, please contact Morgan Gire at morgan@americanmedspa.org to set up your yearly complimentary consultation with a lawyer at ByrdAdatto.

James M. Stanford is an attorney and partner at the ByrdAdatto law firm. From transitions, mergers, and acquisitions to structuring complex ownership arrangements, James enjoys the personal reward that comes from bringing parties together and making deals happen. James practices primarily in the areas of health care and corporate law with a focus on intellectual property. A proud father, Jim served in the U.S. Army and is fluent in Russian. In his spare time, he enjoys hunting, fishing, and spending time outdoors. 

Tags:  Med Spa Law 

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Dermaplaning: Surgery or a Close Shave? Part 2

Posted By Administration, Friday, January 4, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

This is a continuation of a piece on post on dermaplaning. To read the first part of this blog, click here.

How have other states approached dermaplaning and its perceived duality? Other states have approached this dual nature of dermaplaning as both a cosmetic treatment and a medical procedure by permitting cosmetologists and estheticians to perform dermaplaning but only under the supervision of a physician.  Utah is one such state, they allow master estheticians to perform dermaplaning under the direct supervision of a health care practitioner.

The layer of skin effected is not the only area of concern for Dermaplaning.  In states such as Texas estheticians and cosmetologists are permitted to perform microdermabrasion procedures as long as they only remove dead skin cells.  This is similar to some of the previously listed states.  However, Texas estheticians and cosmetologists are not allowed to perform dermaplaning regardless of the layer of skin effected.  The reason is that using a bladed implement on the face is considered shaving and only barbers are licensed to shave the face.  The similarity to shaving is also at play in New Jersey where barbers and master barbers can perform dermaplaning. 

It appears that most states have at least some restriction that limit or prohibit esthetician’s and cosmetologist’s ability to dermaplane. Some strictly limit the depth of skin that can be affected.  Some make it a medical procedure and require that it be performed under medical supervision or by medical practitioners.  Medical spas that are considering offering dermaplaning services should certainly review their own state’s specific rules on the procedure (AmSpa Members can refer to your state’s summary here). 

Tags:  Med Spa Law  Med Spa Trends 

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Dermaplaning: Surgery or a Close Shave? Part 1

Posted By Administration, Thursday, January 3, 2019

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

Dermaplaning over the last couple of years has become one of the most popular procedures offered in medical spas. There are, however, differing opinions on who may do the procedure and whether or not it is medical in nature. Let’s take a brief look at how different states treat dermaplaning and some consideration if you plan to offer dermaplaning in your medical spa.

Before we dive into the details let’s do an overview of what is dermaplaning. Dermaplaning is a form of mechanical exfoliation. It typically involves a bladed instrument (often a #10 scalpel) used to scrape off the dead layer of skin and small hairs from a person’s face. The patient is left with more vibrant and even looking skin. In that respect it is similar to microdermabrasion treatments in that it should only remove the stratum corneum (outermost layer of skin).

Dermaplaning has the added benefit of have much lower equipment costs since it needs only a scalpel to perform as opposed to more elaborate machinery. This difference in equipment can complicate who may perform the procedure, as we will see later.

Since the procedure is intended to only effect the stratum corneum layer of the skin and not any lower it would seem that estheticians or cosmetologists would be able to perform these procedures as part of their practice of beautifying and enhancement of skin that we find in many state’s statutes. This is the case in Ohio were dermaplaning is permitted provided it only removes the cells from the top layer of skin. Dermaplaning (or using a blade) that removes skin cells below the stratum corneum is specifically listed as a prohibited act in the Ohio Board of Cosmetology rules. Tennessee likewise prohibits any type of skin removal technique that effects the living layer of facial skin. Minnesota allows their master estheticians perform treatments on the epidermal layer which is a deeper level than the stratum corneum and so they are allowed to dermaplane.

The depth of a few skin cells can seem like a very narrow margin between what is permitted or prohibited. Other states such as California have come down on the other side line and consider it a strictly medical procedure. In their rules California not only specifically lists “exfoliation below the epidermis” as an “Invasive Procedures” but also consider the removal of skin by a razor-edged tool to also be “invasive.” Illinois similarly prohibits cosmetologists and estheticians from performing dermaplaning and instead consider it a medical procedure. Likewise, South Dakota prohibits estheticians and cosmetologists from performing “invasive” procedures and specifically counts dermaplaning among them in an advisory statement. And in Montana’s administrative rules they define “dermaplane” as being performed by a physician.

Stay tuned for part 2 of “Dermaplaning: Surgery or a Close Shave?” tomorrow!

Tags:  Med Spa Law  Med Spa Trends 

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What Procedures Can an LVN Perform in Texas Medical Spas? The Texas Nursing Board Has Answers… Kind Of

Posted By Administration, Thursday, December 20, 2018

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

The recent medical spa related arrests in the Houston, Texas area (see here and here) have raised many questions and concerns in the Texas medical spa community. What is a licensed vocational nurse’s role in a medical spa? What are they able to do? How do I not go to jail? Fortunately, the Texas Board of Nursing (BON) provides some helpful guidance and resources on this issue that we will explore below.

Scope of practice

The Texas BON does not maintain lists of approved procedures that LVNs may perform. So don’t expect answers to specific treatment questions like, “Can an LVN inject Botox?” Instead, they provide some guidelines that an LVN may use to determine if a particular procedure is within their scope of practice. The scope of practice guidelines are available in full here. It is broken into six steps, which are:

(1)  Determine if particular procedure is within the statutory definition of “vocational nursing” or if it is covered in a guidance document. Of note anything that requires an LVN to make a medical diagnosis or prescribe a treatment will never be within an LVN’s scope of practice

(2)  Determine if there a valid order or protocol authorizing the procedure. LVNs do not practice independently so everything they do must be authorized by a higher level license.

(3)  The procedure must be supported by medical evidence.

(4)  The LVN must personally have the competency and skill to perform the procedure. This competency must be documented by and acquired from their basic, post-basic, or continuing education program.

(5)  The procedure must be within the accepted “standard of care” that a similarly trained and experienced LVN would find reasonable and prudent. 

(6)  And finally the LVN must be willing to accept the consequences of their actions.

The LVN must be able to answer each of these six points in the affirmative for a procedure to be within their scope of practice. In order for a LVN to be able to expand their scope of practice to include new procedures they will need to acquire the competency and skill through an education program. Position Statement 15.10 highlights some limitations of this additional education. The Board believes that informal and on the job training is useful for expanding a nurse’s competency and skills. However only formal education and a higher level of license would allow a nurse to expand their scope past the statutory limits placed on vocational nursing.

Supervision

LVNs do not – and cannot – practice independently. LVNs operate under the supervision of a higher medical licensee, such as an RN, APRN, physician, or physician’s assistant.  Both the Board of Nursing and the Board of Medicine provide guidance on what supervision LVNs need when performing procedures outside the normal scope of vocational nursing.

The Board of Nursing provides Position Statement 15.11 on Delegated Medical Acts . The statement details that a LVN (or RN) may perform a delegated medical act when they (1) have appropriate education and are competent to perform the act (2) their education and skills are documented (3) there are written policies, procedures, or practice guidelines for the act (4) the procedure was ordered by licensed practitioner, and (5) there is appropriate medical and nursing support. The Statement however stresses that the nurse is still expected to adhere to the Standards of Nursing Practice no matter if they are performing a nursing function or a delegated medical act. And that neither RNs nor LVNs are permitted to make medical diagnoses or prescribe “therapeutic or corrective measures”.

These general rules with some additional requirements apply to laser procedures as detailed in Position Statement 15.9. To perform non-ablative laser treatments the LVN/RN must acquire education in safety and use of lasers for medical purposes and document it in their personal record. Further the procedures must have been ordered by a physician, podiatrist, dentist, or a APRN or physician assistant working in collaboration with the prior stated licensees. Since treating adverse reactions will be outside the nurse’s scope there must also be sufficient medical and nursing support. And the nurse will need to comply with any additional requirements from the Texas Dept. of Licensing and Regulation for laser hair removal, if any apply to their situation.

The Board of Medicine has adopted an administrative rule for the supervision of nonsurgical medical cosmetic procedures known as Rule §193.17 . We’ve reviewed Rule 193.17 previously here. It is written as the set of rules a physician must adhere to in providing sufficient supervision and delegation for these procedures. It stresses that it is the physician or midlevel practitioner who performs the initial examination, makes the diagnosis, and develops the treatment plan. 

Continuing Duty

Although the practice of nursing (including licensed vocational nursing) does not include diagnosing or forming courses of treatment, every licensed nurse is required to apply their nursing knowledge in all practice settings in order to fulfill their responsibility to provide safe, effective nursing care to the patient. This duty is detailed in the Board of Nursing’s Position Statement 15.14. In the statement the Board stresses that protocols, policies, and supervisor orders do not surmount the nurse’s duty to act in the best interests of the patient and provide safe and effective nursing care. According to Position Statement 15.15 this duty applies whether the nurse is performing traditional nursing functions or functioning in a different role. 

Licensed Vocational Nurses can be useful and valuable members of a medical spa team. But the LVN license does not have the same scope and authority of midlevel licensees such and physician’s assistants or advanced practice registered nurses. It is critical that the limitations of their license be considered when directing them to perform any delegated medical procedures in the spa. Above you can see that there are numerous considerations for performing any type of procedure, the major points being neither LVNs nor RNs are permitted to make medical diagnoses or prescribe courses of treatment. Additionally, RNs and LVNs must have documented training, education, and written protocols in whatever task they are going to perform and at all times are responsible for providing effective nursing care. The Texas Board of Nursing provides many other FAQs on nursing practice and Position Statements that may prove helpful in developing protocols and supervision arrangements for LVNs in Texas medical spas. 

Tags:  Med Spa Law 

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Who Can Perform Aquagold Fine Touch Procedures?

Posted By Administration, Tuesday, December 11, 2018

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

Aquagold Fine Touch is a channeling device offered for sale by Aquavit Pharmaceuticals that has become extremely popular in the medical aesthetics industry. It delivers micro-droplets of a variety of drugs—typically including Botox and other toxins, as well as fillers—into the skin. What’s more, its manufacturer claims the treatments it provides are pain-free.

Unlike a typical Botox treatment, in which the drug is directly injected and paralyzes the muscle, an Aquagold Fine Touch treatment is essentially microneedling. It delivers tiny amounts of the drug with which it is loaded over a wide area—much wider than a Botox treatment can manage. It is suitable for sensitive areas where Botox is impractical or impossible, such as the neck, and because the doses are much smaller than typical toxin treatments, it tends to result in skin that looks more natural and vibrant. Patients who wish to avoid the “frozen” look that Botox and other toxins often produce are embracing this technology.

As is typically the case when such a product emerges, we at AmSpa are getting a ton of questions about who can actually perform Aquagold Fine Touch procedures. The treatment appears to be very straightforward—a provider simply applies the device to the skin like a stamp. Its simplicity raises an obvious question: Can an esthetician or licensed vocational nurse (LVN) perform this procedure?

It’s good that we’re getting these questions because it shows that medical spa owners and operators care about remaining compliant, but because technology moves faster than the law, it’s sometimes difficult to determine what the answers are when new technology emerges. However, we can use what we know about similar treatments and technologies to determine the most prudent course of action until government agencies make their rulings.

Simply put, the Aquagold Fine Touch is essentially a microneedling device, so a lot of the issues we’ve addressed in recent years regarding microneedling are likely also going to apply to it. Every state that has looked into microneedling has found it to be a medical treatment, so a good-faith exam must be performed before the procedure, and if a doctor is not administering the treatment him- or herself, it must be properly delegated.

Unfortunately for practices that would like to use unlicensed practitioners to perform Aquagold Fine Touch procedures, this takes them out of the scopes of practice for estheticians and LVNs. In addition, the fact that Botox and fillers are being administered raises the question of whether or not this represents an injection and, therefore, if it can be administered only by a registered nurse or, in some cases, a nurse practitioner, physician assistant or physician.

The only conclusion we can draw with any sort of certainty is that Aquagold Fine Touch will be regulated in much the same way as microneedling, both in terms of medical board rulings and FDA approval, which has become a bit of a sticking point for microneedling products recently. Additionally, mixing different drugs together, as many doctors do with the Aquagold Fine Touch device, may represent a violation of pharmaceutical regulations, as many IV bars are finding out. Does a practice need to be registered as a pharmacy and have pharmaceutical oversight? Can nurses do it? Can LPNs? Who is qualified, capable and allowed to do this under the law?

Unfortunately, I don’t have all these answers at the moment, but I am going to find out, so stay tuned to AmSpa for more about Aquagold Fine Touch treatments. Thus far, it has been very safe and very well received, but the industry needs to have a firmer grasp on the regulatory issues surrounding it.

Tags:  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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