[Source: TMSA, Texas Medspa Association 8/11/20]

DRAFT PRACTICE GUIDELINES FOR MEDICAL AESTHETIC PRACTICES BY THE AMERICAN MED SPA ASSOCIATION

The continued success and public support for the medical aesthetic industry hinges on having high quality medical practices that comply with all federal, state and local laws. The industry’s reputation is damaged every time a patient is harmed by poorly trained and supervised individuals, or by media reports demonstrating a lack of understanding of the basic rules governing the provision, delegation, and supervision of aesthetic medical treatments.

At this stage of the industry, however, there is no consistency of rule across state lines. What is legal for medical aesthetic practices in one state might very well be illegal in neighboring states. Laws differ from treatment to treatment and provider to provider. It is therefore difficult to provide a consistent and understandable framework to aesthetic practices intending in good faith to be compliant with all applicable laws.

These guidelines aim to provide that framework, once and for all.

It is our goal that these guidelines become the standard by which all medical aesthetic practices operate, irrespective of their state. To that end, these guidelines are meant to describe the way a minimally compliant medical spa should operate. But given that different states have different rules for different treatments and practitioners, there naturally may be conflict between these guidelines and certain state regulations. To resolve any differences, we recommend that the more restrictive approach be taken in instances where differences exist. In states where the laws or rules are not as strict as these guidelines, these guidelines should be followed. In states with more strict rules, the state rules should be observed. The end result will be a more prosperous industry with stronger and more positive public perceptions and support.

Article I

The Provision of Medical Treatment

1.01 Medical Procedures.

The core of a medical spa’s services are medical procedures meant to enhance the patient’s appearance or improve their health and wellness. While the procedures tend to be less invasive than those typically offered at a plastic surgeon’s office, they are not without risk. Therefore, they must be provided with the same professional skill and care afforded to all medical procedures.

The consistent element of aesthetic medical procedures that differentiates them from non- medical services is their effect on living tissue. A medical spa’s medical services stimulate, alter, or destroy the patient’s living tissue, whereas non-medical procedures effect only the non-living surface of the skin.

Accordingly, as new technology and new treatments are introduced, the practitioner should always fall back on the mechanism under which the treatment achieves its desired result. Does the treatment achieve its result by stimulating, altering, or destroying living tissue? If so, it should be considered a medical treatment. Or put differently, does the treatment’s mechanism impact tissue deeper than the stratum corneum? If so, it should be considered a medical treatment.

How the treatment delivers the mechanism of action is of secondary concern. The real question is what that mechanism of action does to the body. In other words, simply because a treatment does not physically touch living tissue, if the result of its action is to alter living tissue, it is a medical treatment (CoolSculpting, for example, does not fire a laser or energy into tissue, but the result of the application of cold is to destroy living fat tissue, thereby making it a medical treatment).

1.02 Examples of aesthetic medical procedures.

The following is a non-exhaustive list of categories of aesthetic medical procedures. The practitioner should note that this list is extremely broad and may not cover new techniques and devices that are developed.

• laser or energy-based skin and hair removal procedures
• intense pulsed light procedures
• ultrasonic devices
• radio frequency devices
• heating or cyrolyposis devices
• electrical stimulation
• microneedling of any depth
• injection of soft tissue fillers, PDO threads, or neuromodulators
• IV therapy
• dermabrasion beneath the stratum corneum
• medium depth chemical peels (beneath the stratum corneum)

   

  1.03 Non-Medical Procedures.

  Medical Spas do not exclusively offer medical services. Medical Spas may offer services that are complementary to their medical services, but which do not impact living tissue. These may include services that are regulated under each state’s Cosmetology statutes or permanent makeup services that fall under the state’s laws on tattooing. Non-medical treatments include skin exfoliation, light chemical peels, micro-current, hydrafacial type devices, microblading, and cosmetic tattooing.

Non-medical procedures do not need to be provided by medical professionals and are not subject to these guidelines. However, for medical spas to be compliant with these guidelines, any of these complimentary non-medical services must be provided in accordance with state law. This may require employing licensed cosmetologists or esthetician and being licensed as a salon by the state’s cosmetology board.

1.03 State Law Exceptions.

Some states have taken measures to define treatments so that they either automatically become medical treatments, or, conversely, are statutorily defined as non-medical treatments. The most prominent example of this is laser hair removal, which has been regulated as an individual treatment by approximately nine states. In addition, other states like NY have conspicuously not addressed laser hair removal, thereby making it essentially unregulated.

Irrespective of the designation of individual states, the purpose of these guidelines is to provide consistency across state lines. Therefore, AmSpa recommends that, regardless of whether a state has designated a treatment non-medical, if it falls under the above definition of medical – i.e. it impacts living tissue – medical aesthetic practices should treat that treatment as a medical treatment. Accordingly, in a state like New York that does not regulate laser hair removal, we recommend that it be treated as a medical treatment anyway. This is not only safer for the public, but it provides consistency and predictability in the industry.

Comment to Rule 1:

The aesthetic industry is one of constant innovation – new techniques and technologies are always being developed. The purpose of this rule is to provide a single, easy-to- follow standard for how aesthetic procedures, both current and future, should be approached. If the treatment “impacts” living tissue – that is alters, stimulates, or destroys anything beneath the stratum corneum – it should be considered a medical treatment and is subject to these guidelines. Since medical spas bring multiple aesthetic and health disciplines into a single location, if the treatments are not medical, they are not subject to these guidelines. In the past, States and regulatory bodies have addressed medical spas and the procedures they offer in an inconsistent, reactive, and disjointed way if they are addressed at all. By accurately identifying the “medical” nature of aesthetic procedures we can ensure that they are provided in a safe and consistent way that focuses on patient outcomes.

Article II

Medical Directors, Protocols, and Training

2.01 Medical Directors.

As medical practices, every medical spa must be headed and overseen by a supervising physician, commonly called a Medical Director. The Medical Director (or supervising physician if not called a Medical Director) is a licensed physician who is professionally responsible for all

of the medical procedures provided at the medical spa. They may delegate the authority to perform treatments to certain practitioners who have the training and skill to safety perform the procedures, but they still retain ultimate responsibility for the medical treatment provided at the practice.

2.02 Medical Director Requirements.

The medical director has the ultimate responsibility to ensure that the medical spa is operating in a safe and compliant manner. To be able to effectively and appropriately supervise a medical spa, the medical director must:

(a)  Possess the appropriate education, training, experience and competence to safely administer, delegate and supervise each aesthetic medical treatment at the Medical Spa;

(b)  Ensure appropriate supervision of each medical aesthetic treatment performed by at the Medical Spa;

(c)  Accept ultimate responsibility for the safety of the patients treated at the medical spa;

(d)  Ensure that the medical spa’s providers are trained and qualified to provide the procedures they have been tasked to provide;

(e)  Ensure the medical spa is equipped with all necessary equipment, supplies and processes to address medical complications and emergencies; and

(f)  Develop and sign written protocols for aesthetic medical treatment to be performed at the medical spa.

To be clear, it is against the prevailing standard of care for a physician (or NP/PA where applicable) to (i) accept the responsibilities of a medical director without being trained and qualified in all medical procedures performed at the medical spa, (ii) delegate treatments while not being trained and qualified in the procedures they are delegating; or (iii) fail to ensure proper supervision, training and qualification of providers at the medical spa.

2.03 Protocols.

In order to increase consistency and quality of care, every medical treatment or procedure offered in a medical spa must have a detailed written protocol or standard operating procedure (SOP) developed by the Medical Director or responsible physician (or NP/PA where applicable). The protocols should provide detailed procedures to be followed in administering the treatments and provide guidance on addressing and responding to adverse incidents. The protocols should be specific enough so that medical decisions are not left to the discretion of the non-physician provider.

2.04 Independent practice of NPs and PAs.

Many states, and more each year, have adopted “independent practice” statutes for nurse practitioners (NP) and physician assistants (PA). In these states, NPs and/or PAs have the authority to practice independently – i.e. without a supervising physician – provided all requirements of the state’s independent practice law have been satisfied. These licensed independent practitioners can serve as medical directors and owners under these guidelines, subject to the restrictions their state places on their scope of practice, ownership of professional entities, or authority to delegate medical spa procedures. Accordingly, the guidelines relating to “Medical Directors” or “physicians” also apply to NPs and PAs who (i) have independent practice laws in their state, and (ii) are in compliance with all requirements of the state’s statutes and regulations.

2.05 Training.

The Medical Director and every provider, whether licensed or unlicensed, must have appropriate training in the treatments they provide. Specific training varies from procedure to procedure, but at a minimum must include a hands-on, practical component in addition to any classroom training. The training should provide significant information on identifying and addressing complications or adverse incidents in addition to the direct techniques and theories of the procedure. Introductory-type training as often provided by device manufacturers can make up a component of a provider’s training but cannot be the sole source of instruction. All persons should maintain and develop their acquired skills though periodic additional training or directly supervised demonstrations.

It is the Medical Director’s (or supervising physician, NP or PA where applicable) responsibility to ensure each provider is trained and qualified to perform the treatments they are tasked with performing.

2.06 Training Requirements. [RESERVED]

Comment to Rule 2:

One of the biggest challenges the industry faces are medical spas being run either without proper physician supervision or by physicians who are unqualified to do so. Since these are medical treatments, medical spas need to be overseen by physicians (or in states that allow for it, NPs or PAs), known as Medical Directors. These guidelines establish with finality that a medical spa’s Medical Director must be trained and qualified to perform and supervise ALL treatments performed at the medical spa. Further, the medical director is ultimately responsible for all medical treatments that are performed at the medical spa, as well as all practitioners who provide treatments at the medical spa. Further, all medical directors and providers must be properly trained in the procedures they are providing, and it is the Medical Director’s responsibility to ensure such training and qualification is obtained by every provider at the medical spa. AmSpa is in the process of developing explicit training guidelines for medical spas.

Article III

Initial Examination, Diagnosis and Treatment Plan

3.01 Examination Prior to Treatment.

Prior to any medical aesthetic treatment, an initial face-to-face examination of the patient should be performed by a qualified physician. This initial examination should consist of, at a minimum, the taking and review of a medical history and appropriate physical exam.

3.02 Diagnosis and Treatment Plan.

Once the initial examination is complete, a diagnosis and treatment plan for each medical treatment should be developed by the qualified physician. The treatment plan should include, at a minimum, instruction on doses, settings, and specific areas of treatment. The treatment plan may provide for a course of treatment over a period of time or a number of treatments. Provided the patient’s health situation remains unchanged, a patient examination is not required before every visit under the treatment plan (although we recommend a consultation at least every twelve months). Changes in the patient’s situation or the application of new procedures would necessitate a new examination, diagnosis, and treatment plan.

3.03 Exceptions.

a)  NPs or PAs may perform the initial examination, diagnosis, and treatment plan if they are trained and qualified to do so and have met all applicable state requirements for doing so.

b)  Telemedicine may be used for the initial exam provided that (i) it is performed by a qualified physician (or NP/PA when applicable); (ii) applicable state telemedicine requirements are met and followed; (iii) the physician (or NP/PA when applicable) can, through telemedicine, perform the same quality of physical examination, diagnosis and treatment plan as if they were in the same room; and (iv) proper consents are obtained and proper documentation made in the patient’s medical record.

Comment to Rule 3:

Every patient must be directly examined by a licensed professional who is able to make medical diagnosis and prescribe treatments, such as a physician. In many states, nurse practitioners and physician assistants are also permitted to examine and prescribe treatments. The examination must be face-to-face, where the practitioner directly observes the patient and is not working solely from static images or charts. The purpose of the exam is twofold: one, to ensure that the patient does not have any health concerns which would prohibit them from receiving the procedure, and, two, to determine which specific treatment and what settings and dosages are appropriate to achieve the patient’s desired outcome.

Following the exam, the practitioner must develop a written treatment plan, which identifies the treatments, treatment sites, device settings or dosages, and frequency. This treatment plan, in conjunction with a procedure-specific protocol, provides guidance and instruction for the delegated practitioner to follow.

Nurse Practitioners and Physician Assistants may be delegated the initial examination and treatment plan, provided they have met all state regulations for doing so. In addition, in most circumstances the examination must be done in person and face-to-face, but in states that allow for physicians to practice using telemedicine the exam can be performed remotely. If the practitioner chooses to employ telemedicine, the live video feed must be of sufficiently high fidelity and definition so as to provide the same or superior view as they would have if they were directly observing the patient in person. Low resolution video lacks the detail needed to make an effective determination or to notice potential contraindications to treatment. Low resolution telemedicine is inappropriate to use in a medical spa setting.

Article IV

Provision of Medical Services, Delegation and Supervision

4.01 Provision of Medical Services at a Medical Spa.

Once a proper initial examination and diagnosis are made and a treatment plan developed, the performance of the treatment may be performed by, or delegated to, a qualified provider under the following minimum requirements:

a)  The provider is trained and qualified to perform the specific treatment;

b)  The provider is properly supervised;

c)  Proper protocols have been developed by the qualified supervising physician or Medical Director to address complications and adverse events.

4.02 Standard of Care.

The medical procedures offered by medical spas must be provided in accordance with the prevailing standard of care and only by trained and qualified providers in a manner that maximizes the patient outcomes and minimizes complications or injuries.

4.03 Delegation of Medical Services.

Delegation is the formal process where a physician (or NP/PA where applicable) transfers the authority to perform a treatment to another person. The delegating professional retains all professional responsibility to ensure that the treatment is carried out in accordance with the prevailing medical standard of care.

Procedures and treatments should only be delegated to persons who are qualified, i.e. trained and skilled in the specific procedure. Often the necessary training and skill will require that the person hold a professional license such as a nurse or physician assistant in addition to treatment specific training.

Once a proper initial examination and diagnosis are made and a treatment plan developed, the performance of the treatment may be delegated to a qualified practitioner who practices under the supervision of an appropriate medical professional under the following
minimum requirements:

a)  The delegated provider is trained and qualified to perform the specific treatment;

b)  The delegated provider is properly supervised;

c)  The delegating and supervising practitioner(s) is/are qualified

d)  Proper protocols have been developed by the qualified supervising physician to address complications and adverse events;

4.04 Supervision.

Supervision is the process where the physician or an advanced licensee such as a PA or NP monitors and oversees the delegated practitioner during the performance of the procedure. The levels of supervision vary based on the skill and license of the person who is delegated the procedure and the difficulty and risks of the procedure. In all instances, the supervising professional must be able to respond immediately to address complications or emergencies.

Different levels of supervision referenced in these guidelines include the following:

a)  General or Indirect Supervision. The physician or supervising practitioner is off-site but immediately available by telecommunication;

b)  Direct Supervision. The physician or supervising practitioner is on-site and able to directly observe the treatment being performed, though not necessarily in the same room at all times.

Comment to Rule 4.

At the heart of these guidelines is the requirement that medical aesthetic treatments only be performed by, or delegated to, qualified and trained professionals under proper supervision. After the proper examination and treatment plan, medical aesthetic treatments may be delegated and performed only if the provider, the delegating practitioner, and the supervising provider are trained and qualified in the treatment(s) being performed and delegated. The type of supervision varies depending on the type of treatment and the practitioner performing the treatment, but regardless it is recommended that a practitioner with a license of RN or above (PA, NP, or physician) be present at the facility at all times.

Article V

Restrictions on Certain Medical Treatments and Providers

5.01 Restrictions of Specific Treatments.

Certain medical aesthetic treatments have more affiliated risk than others, and the risk of serious complications and/or side effects in certain treatments demands that only certain licensed and medically trained practitioners provide those treatments. Regardless of whether state regulations allow other practitioners to perform these treatments, it is our recommendation that aesthetic practices adhere to these guidelines for the following medical aesthetic procedures.

a)  Ablative lasers or ablative energy devices. Ablative lasers are intended to excise or vaporize the outer layer of skin. These procedures should only be performed by a physician, or delegated to an appropriately trained RN, NP, or PA with the physician directly supervising the procedure in the same room.

b)  Non-Ablative Lasers, Light Treatments, and Energy Device Treatments. Non- ablative treatments that do not excise or vaporize the outer layer of skin can be provided by physicians, NPs, and PAs. These procedures may be delegated to RNs and LPNs/LVNs under general supervision, provided a qualified RN or above (PA, NP, or MD/DO) is onsite. MAs may be delegated these treatments under the direct, onsite supervision of a physician, NP, or PA.

c)  Microneedling. Microneedling treatments, irrespective of depth, can be provided by physicians, NPs, and PAs. RNs may be delegated these treatments under general supervision. LPNs/LVNs, and MAs may be delegated these treatments under the direct, onsite supervision of a physician, NP, or PA.

d)  Injection of fillers, neuromodulators or PDO Threads. Injectable treatments such as fillers and neuromodulators, and the insertion of PDO Threads, may be performed by physicians, NPs, and PAs. These procedures may be delegated only to trained and qualified RNs acting under the general supervision of a physician, NP, or PA.

Regardless of the level of skill or training, all non-physicians who perform aesthetic medical procedures must operate only under appropriate supervision and according to written Protocols developed by the Medical Director.

5.02 Licensed Medical Professionals.

Licensed medical professionals, such as NPs, PAs, RNs, LVNs, and LPNs, must adhere to their professional scopes of practice and follow the direction of their respective licensing boards. In addition to acting within their statutory scope of practice, all licensed professionals must receive training in the specific services they are delegated as defined in these guidelines. Except where

specifically noted, these professionals perform their services under the delegated authority and supervision of the medical director.

5.03 Non-medical professionals and Medical Assistants (MAs).

Medical spas may choose to employ other unlicensed, non-medical professionals to provide certain limited services. These unlicensed professionals are typically called Medical Assistants. Medical Assistants are unlicensed persons who have received training and instruction in certain healthcare services. Medical assistants may be utilized in medical spas and may perform certain treatments as provided in these guidelines. Because they lack formal medical training, the variety of tasks they may perform are restricted and they must operate under closer supervision than licensed medical professionals.

5.04 Laser Technicians.

The vast majority of states have not enacted any certification or licensure for operation of an aesthetic laser or light or energy emitting device. Accordingly, in most states, the term “Laser Technician” is a misnomer and carries no formal meaning. In states that have not enacted any licensure or certification for these devices, Laser Technicians are defined as Medical Assistants specifically trained on certain laser, light, or energy emitting devices. Because they have received no formal medical training, they are subject to the same higher level of supervision as Medical Assistants.

Some states have enacted specific certifications for aesthetic laser treatments (usually, if not exclusively, laser hair removal). In these states, Licensed or Certified Laser Technicians may act only within the scope of the laser certification law of their state.

5.05 Estheticians and Cosmetologists.

Estheticians and cosmetologists may provide services in accordance with the statutory scope of practice and as permitted by their professional licensing boards. Some states expressly permit estheticians to provide certain skin treatments that would otherwise be considered aesthetic medical procedures (“master estheticians”). In these instances, these treatments may be provided in a medical spa with the approval of the medical director and in compliance with the cosmetology board’s requirements. While estheticians and cosmetologists are restricted in performing any medical treatment, in some instances they may be dually trained as a Medical Assistant and may perform certain treatments under direct supervision.

5.06 Dentists.

Dentists who hold a traditional dental license (DDS) may practice within their statutory scope of practice and as permitted by their professional licensing boards. This may include cosmetic treatments and dentistry performed on the teeth, gums, oral cavity, lips, and area around the mouth. Treatments involving the rest of the face, head, neck, or body are generally outside of their professional scope, even if they are otherwise skilled in the treatment. Dentists may not

serve as Medical Directors for a medical spa as they cannot lawfully supervise most medical spa procedures, nor can they lawfully delegate or supervise these procedures in every instance.

Comment to Rule 4:

For the avoidance of any doubt, injectable treatments may only be performed by RNs, PAs, NPs, and physicians, provided they are properly trained and qualified to perform those treatments. Aestheticians, medical assistants, LPNs, LVNs, or any other provider may not perform injectable treatments under any circumstances, regardless of any certification, training or direct supervision.

With respect to laser treatments or any light or energy emitting device, the goal here is to ensure that a qualified, licensed medical provider is on site to address any complications or adverse reactions. Therefore, a physician (or NP/PA where applicable) may delegate non-ablative energy treatments to unlicensed personnel, such as medical assistants, provided an RN or above is onsite during the treatment.

Many states have adopted licensing laws that allow people to perform laser hair removal or other limited laser or light procedures under specific circumstances. These licensed laser practitioners may perform only the procedures allowed in their statutory scope of practice and under conditions and supervision as required by their license. For other medical aesthetic treatments outside of their scope of practice they would be treated as MAs.

Article VI Ownership and Compensation

6.01 Ownership and Compensation.

Most states (but certainly not all) observe some version of the Corporate Practice of Medicine (CPM), which restricts ownership of medical practices to physicians. As medical practices, all medical spas and medical aesthetic practices must adhere to ownership rules in their respective states, including strict adherence to the CPM, if applicable. Similarly, medical aesthetic practices must adhere to those state laws that prohibit paying commissions for medical treatments, have fee-splitting prohibitions, or specific anti-kickback regulations. Regardless of the state ownership and compensation requirements, the following standards shall be followed by all medical aesthetic practices:

a) A physician (or NP/PA where applicable), must be in charge of all medical treatments including developing protocols and ensuring that all examination, delegation, and supervision requirements followed;

b) The medical aesthetic practice in general, and the supervising physician specifically, must ensure that all medical treatments are provided for the health and well-being of the patient.

6.02 Independent practice of NPs and PAs.

Many states, and more each year, have adopted independent practice for nurse practitioners (NP) and physician assistants (PA). Each state’s laws and regulatory boards for these professions govern the scope of practice and ability to delegate procedures to others. These licensed independent practitioners can serve as medical directors and owners under these guidelines subject to the restrictions their state places on their scope of practice, ownership of professional entities, or authority to delegate medical spa procedures.

Comment to Rule 5:

The Corporate Practice of Medicine (CPM) is alive and well in the United States. Since Medical Spas are medical practices, they therefore need to be owned in accordance with their state’s laws on medical practices. This will mean that in states that observe the CPM, a licensed physician or group of physicians will need to own the medical spa. They may be able to jointly own with other health professionals or other persons, depending on state rules. In states that allow for non-physician ownership of medical practices, every medical spa must have a licensed physician as a medical director. The physician medical director must be able to independently exercise their professional judgment without influence or restriction. This extends to all aspects of the medical treatment process, including hiring and firing medical employees, choosing equipment and device, setting hours and prices, and developing training and protocols for the medical spa. Regardless of how the medical spa is owned, the licensed physician is the person ultimately responsible and liable for the safe and effective provision of all medical procedures at the medical spa. While ownership can take many forms, it is important that it adhere to local requirements.

The purpose of 6.01(b) is to ensure that, regardless of the flow of funds, revenue, and how providers are compensated (or how much they are compensated), a physician is in charge of medical treatment. Devices, types of treatments, final hiring of providers, protocols and SOPs, safety measures, pre-qualification, disqualification…all those medical decisions must be under a physician’s purview. The purpose here is to ensure that patient care drives corporate revenue, not the other way around. We must not allow the business metrics – revenue per treatment, margin per treatment, etc. – which is often influenced by non-physicians, to dictate the level or quality of patient care. Physicians practice medicine for the benefit of the patient, and ownership and compensation structures should not change that.