Is Your Medical Spa Legally Compliant?

Is Your Medical Spa Legally Compliant?

The term “medical spa” generally refers to a facility or business that offers “traditional, complementary, and alternative health practices and treatments in a spa-like setting.”[1] A medical spa may offer a hybrid or combination of medical and cosmetic procedures.

Medical spa businesses, though not always identified as “medical spas” specifically, have been around since the 1990s. But the market for medical spa (or medi-spa) services is on the rise. As of 2018, more than 5,000 identified medical spas were operating in the U.S.[2]

According to a 2018 report, the global medical spa market is projected to reach $27 billion by 2025.[3] One would think a global pandemic that requires social distancing and more work-from home arrangements would subdue a desire for aesthetic or beautifying services.

Apparently, the opposite is true. One article notes a higher demand for aesthetic services “due to the exponential increase in Zoom and virtual meetings, conference calls, and classwork.”[4] In other words, video chats zero in on facial features, and people want to look their best.

For those in the medical spa business, or those hoping to start one, there are a myriad of legal considerations to think about and little guidance. Absent federal regulations, regulation of medical spas varies by state, and few states have specific regulations relating to medical spas.

Instead, those in the medical spa industry must navigate a patchwork of statutes and regulations that regulate specific procedures, as well as the licensing and supervision requirements that apply to the individuals who are performing the services.

Is it Medical Procedure? Or is it a Cosmetic Procedure?

It may be tempting to view cosmetic procedures as non-medical. Services such as exfoliation, chemical peels, microdermabrasion, surface micro-needling, and electrotherapy may seem like simple procedures that may be performed independently, with no oversight or supervision.

Don’t make that mistake. These types of cosmetic procedures will most always require the person performing them to be a licensed professional – such as a cosmetologist, aesthetician, or nurse – and there may be specific regulations that apply to those specific services.

Other more invasive procedures, such as cosmetic injectables (Botox), dermal fillers, deep micro-needling, skin removal, or laser treatment will almost always require a physician to delegate those services, and provide some form of supervision and oversight.

Medical spa professionals should always understand what procedures they are licensed to perform, and what level of supervision is required. Practicing beyond one’s “scope of practice” can lead to disciplinary action by a regulatory board in your state, or even criminal prosecution.

In Texas, for instance, a nurse was charged with a felony for practicing medicine. She was administering Botox injections without physician supervision, which is illegal in Texas.[5]

Scope of Practice

Think of the practice of medicine as house with many rooms. Each room provides different types of services, from orthoscopic surgery and liposuction to microdermabrasion and chemical peels. If qualified to do so, the physician can perform all services within the house.

If a registered nurse or nurse practitioner is properly licensed and qualified to perform the services, their “scope of practice” may allow them to perform numerous services within the house, so long as those services are delegated and supervised by a physician.

But other professionals must stay within their specific rooms. For instance, a cosmetologist or aesthetician may be limited to a handful of procedures. It all depends on what the state allows within their “scope of practice,” and each state has different scope of practice rules.

For instance, in Arizona, registered nurses, licensed practical nurses, advanced practice registered nurses, licensed cosmetologists, and licensed aestheticians can perform medical aesthetic procedures if they demonstrate necessary education, training, and licensure.[6]

However, the level of supervision is based on a three-tiered system of classification, assessing risk to the patient. While a level one procedure does not require supervision, a level three procedure must be performed under medical supervision of a physician with specific knowledge, skills, and abilities in the medical/cosmetic procedure.[7]

Advanced practice registered nurses (APRNs) can also serve as “medical directors” in Arizona because APRNs enjoy a higher level of autonomy than nurse practitioners in other states.[8]

In other states, such as Wisconsin, a cosmetology license allows a licensee to perform certain “delegated medical procedures,” including laser hair removal and chemical exfoliation, but only as directed, supervised, and inspected by a physician.[9]

Because of the financial potential, physicians may be tempted to serve as “medical directors” to medical spas and provide the necessary oversight and supervision. Before entering these arrangements, physicians should carefully consider what level of supervision is required.

Failing to provide proper supervision – or being an absentee medical director — may violate regulations and lead to liability exposure if something goes wrong and a patient is injured.

Corporate Practice of Medicine

Another aspect for medical spa professionals to consider is the legal doctrine known as the “corporate practice of medicine.” Under corporate practice of medicine laws – on the books in most states – physicians must have at least some financial ownership interest in a medical practice. In states with strong enforcement, non-physicians cannot own a medical spa.

The corporate practice of medicine is concerned that a physician’s independent medical judgment could be compromised if a non-physician-owned business is running the show and providing financial incentives in return for the physician’s involvement.

Thus, if a physician is servicing as a “medical director” on a contract basis, with no ownership interest in the medical spa, this could violate the corporate practice of medicine law. Consider California, which has one of the nation’s strongest corporate practice of medicine laws.

Under Cal. Bus. & Prof. Code § 2417.5, a person can be found guilty of a felony, punishable by imprisonment and up to a $50,000 in fine if a business organization “offers to provide, or provides, outpatient elective cosmetic medical procedures or treatments … and that contracts with, or otherwise employs, a physician and surgeon to facilitate its offers to provide, or the provision of, outpatient elective cosmetic medical procedures or treatments that may be provided only by the holder of a valid physician’s and surgeon’s certificate.”

In other words, medical practices must be owned by physicians. A medical spa that contracts with a physician to be a “medical director” could be in violation of this law.

The corporate practice of medicine statutes may be less strict in other states, or other states may not strictly enforce its corporate practice of medicine laws. But medical spa professionals should understand the risks involved before entering into these arrangements.

Delegation and Supervision

A physician with training and experience to perform medical procedures can delegate those procedures to other health care professionals to perform them, so long as the physician knows that person is qualified to perform the procedures and there is proper supervision.

State laws and regulations will govern what medical procedures may be delegated, and what types of licensed professionals may perform the delegated procedures. The laws and regulations will also include other requirements, such as the need for written protocols.

Under Wisconsin’s cosmetology regulations, for instance, delegated medical procedures must be undertaken pursuant to formal written protocols “setting forth the nature and scope of the procedures delegated, describing the supervisory plan, and indicating any contraindications to undertaking the procedure.”[10]

Other regulations, such as regulations that apply to nurses, may govern the delegation of medical procedures and the specific requirements for supervision.

Because most states lack specific “medical spa” regulations, practioners must draw from a patchwork of laws and regulations that may apply in order to minimize compliance risk.

Thus, health care professionals or other licensed individuals hoping to start medical spas must understand the regulatory landscape in their specific state.

Each state will have their own requirements for who can perform cosmetic medical procedures, who must supervise those activities, and other protocols and procedures that a medical spa must follow to comply with applicable statutes and regulations.

In some cases, a lack of guidance may require a medical spa to analyze and follow a patchwork of laws or regulations that apply to scope of practice and supervision requirements but do not address the specific practices of the hybrid medical spa.

Enforcement and Liability

The point of ensuring compliance with statutes and regulations that apply to medical spa activities – beyond ensuring the patient’s safety — is to mitigate the risk of adverse regulatory actions, including monetary fines, disciplinary action, and even imprisonment.

A person who is performing cosmetic medical procedures without a proper license could be prosecuted for unlicensed practice of medicine, which could be a criminal offense in some states. In addition, a person who is not providing proper oversight or supervision of cosmetic medical procedures could face disciplinary actions for misconduct.

On top of regulatory enforcement actions, a host of civil legal theories that can be used against medical spas, including negligence, medical malpractice, and lack of informed consent. That is, if a patient/client is harmed in some way, they may have viable claims for a civil lawsuit.

A plaintiff could be entitled to damages if the medical spa is deemed negligent by failing to meet a proper standard of care to ensure patient safety. That may be proved by lack of supervision, lack of proper protocols/procedures, or lack of training or licensure.

A medical spa’s failure to obtain a patient’s informed consent could be another basis for determining liability. Informed consent laws ensure a patient understands the risks and benefits of a particular medical procedure before they agree to have it performed.

Professionals contemplating a medical spa or currently associated with a medical spa business should understand the state-specific statutes and regulations that apply to those activities, with the help of competent legal counsel to address the specific circumstances.

Contact the health lawyers at the Center for Health and Wellness Law, LLC to help you with legal compliance for your medical spa.

Endnotes

[1] National Coalition of Estheticians.

[2] American Medical Spa Association, 2019 Medical Spa State of the Industry, Infographic.

[3] PR Newswire, Global Medical Spa Market Expected to Reach $27,566 Million by 2025, Says Allied Market Research (July 12, 2018).

[4] American Spa, AAFPRS Sees a Spike in Requests for Aesthetic Treatments (Nov. 8, 2020).

[5] ABC 13, Nurse accused of unlicensed Botox injections at Spring spa (Nov. 8, 2018).

[6] Arizona State Board of Nursing, Advisory Opinion: Medical Aesthetic Procedures Performed by Licensed Nurses, Licensed Cosmetologists, Licensed Aestheticians, and Certified Laser Technologists (Revised 03/2019).

[7] Id.

[8] Id

[9] Wis. Admin Code. Cos 2.025(1)-(2).

[10] Wis. Admin Code. Cos 2.025(3).

Back to blog