Creating a Better Medical Aesthetics Industry

Medical aesthetics is an amazingly vibrant, fast-growing industry that really is still just scratching the surface of its potential. According to the American Med Spa Association’s (AmSpa’s) 2019 Medical Spa State of Industry Report, it was expected that in 2019 or 2020, the industry would eclipse $10 million in revenue; the report also estimated that by 2023, the industry’s revenues would nearly double. (Of course, this was prior to the COVID-19 pandemic, and it is unclear what its long-term effects on medical aesthetics will be.)

However, with greater success comes greater scrutiny, and medical aesthetics has begun to experience the sort of enforcement that more established medical practices have had to deal with for many years. Laws vary from state to state, and something that might be perfectly legal in one state may be against the law in another.

As such, creating a series of guidelines designed to help all medical aesthetic practices and medical spas remain compliant was a formidable challenge. It took more than a year for AmSpa, working in conjunction with the attorneys of ByrdAdatto and numerous medical aesthetic thought leaders, to create the initial version its Practice Guidelines for Non-Surgical Aesthetic Practices (Medical Spas) and, although they remain a work-in-progress, AmSpa is proud to do its part to help medical spa owners and operators achieve the success they deserve without worrying about regulatory agents knocking at their doors.

Medical Above All

First and foremost, medical spas offer medical treatment. The most important word in “medical spa” is “medical.” This industry offers medical aesthetic services. This is what makes medical spas different from regular day spas. It offers medical solutions, using medical devices and drugs, provided by medical professionals.

For many, this is self-evident. But for some in the industry, coming to terms with the medical nature of medical aesthetic services is not so easy. In some ways, it’s easy to understand why—the treatments are non-surgical, they often have few side-effects and, let’s face it, some procedures are pretty easy to perform. Laser manufacturers have done an exemplary job of developing equipment that is straightforward and efficacious.

But even if this is true, it is time for the industry to recommit to the medical aspect of aesthetic treatments.

This definitely doesn’t mean that physicians must own all medical spas, or that registered nurses (RNs) and aestheticians should be sidelined. Not at all. Rather, it is well past the time for the industry as a whole to understand that, when you administer medical procedures, you must follow medical regulation. It is impossible to have your cake and eat it, too, in this regard. The medical aesthetic industry can’t differentiate itself from over-the-counter anti-aging devices by claiming to offer medical results and then skirt the regulations that are designed to make medicine safe.

Laser and light-emitting devices are FDA approved. Neurotoxin is a drug. There’s a reason why device manufacturers go through months of clinical tests to get safety approval for specific treatments, or why physicians use the term “off label” when they talk about treatments outside the approved treatment areas, or why a physician’s signature is required to order product. These measures prove that those in this industry are medical providers—not just providers.

Guiding the Way

AmSpa recently released its Practice Guidelines for Non-Surgical Aesthetic Practices (Medical Spas) for review. For anyone who has followed AmSpa for the past several years, the contents of these guidelines should not be a surprise. AmSpa has not tried to change the landscape of medicine; to the contrary, it summarizes, in easy-to-understand language, what the law already is: These are medical treatments and, therefore, medical laws need to be followed. For those who are new to AmSpa, this has been the drumbeat to which the organization has been marching for more than seven years. It’s the entire reason AmSpa was started in the first place.

And yet, the guidelines created a great deal of controversy when they were released. Some folks were upset that AmSpa would maintain that a medical spa would need a physician’s involvement. Or that injection of filler—which can, if not performed properly, cause blindness—would need physician oversight at some level. Many objections AmSpa received did not focus on the fact that the guidelines maintain that, in most instances, physicians can properly supervise while off-site or that initial exams can be held over FaceTime. Rather, some objections expressed indignation that physicians needed to be involved at all.

It’s time to set the record straight. The practice of medicine is, and has always been, the purview of physicians. This doesn’t mean that other providers can’t be involved, both as injectors and owners; it simply means that in almost every case, a physician must be involved—the only exceptions are due to recently passed independent practice laws for APNs. Otherwise, there would be no “medical” in medical spa.

Long Story Short

It’s time for the industry to fully and finally accept the basic standards that have governed medical practices for more than a century. In order to summarize and clarify the Practice Guidelines, AmSpa has created the “The 10 Basic Rules of Aesthetic Compliance.” These are 10 basic rules that define, in a general sense, what a medical aesthetic practice needs to recognize in order to remain compliant.

1. Medical spa treatments are medical treatments.

2. Medical spas are regulated as medical facilities (e.g., doctor’s offices).

3. Medical spas shall be supervised by a physician, or nurse practitioner (NP) or physician assistant (PA), under appropriate circumstances.

4. The supervising physician (or NP/PA, under appropriate circumstances) must be trained, qualified, and experienced in all medical treatments performed at the medical spa.

5. A face-to-face examination, including appropriate history and physical, must be performed by a physician (or NP/PA, under appropriate circumstances) who is trained, qualified and experienced in the desired medical procedure before the initial medical procedure is performed.

6. Medical spa treatments must be performed by trained, qualified, and experienced practitioners under the supervision of a physician (or NP/PA, under appropriate circumstances).

7. Standard operating procedures and treatment protocols shall be implemented and approved by the supervising physician (or NP/PA, under appropriate circumstances).

8. Only RNs and above (i.e. NPs, PAs, and physicians) may inject.

9. State ownership and revenue-sharing laws shall be obeyed.

10. Patient privacy must be protected at all times.

None of these rules are new—they have been in place in nearly all states for many years, long before the term “medical spa” was invented. What’s more, none of these rules are meant to favor one group over another. They are, instead, a summary of the basic laws of medical practice in the aesthetic context.

Next Steps

AmSpa has received much feedback and is taking everything shared into consideration. Some issues have been raised by organizations trying to undermine us (trust me, we do not believe that all medical spas need to be owned by a physician), but most of them have led to productive conversations and helped AmSpa focus on what matters to its members and practitioners everywhere.

AmSpa has also created the AmSpa Aesthetic Safety Council (AASC) to help further the goal of promoting compliance, safety, and profitability throughout the medical aesthetic industry. The AASC consists of medical aesthetic industry professionals from different practice levels—including physicians, APRNs/NPs, RNs, PAs, and owners—who will review and provide feedback on the Practice Guidelines for Non-Surgical Aesthetic Practices (Medical Spas), as well as guide AmSpa to ensure that it is helping to make the medical aesthetic industry more compliant, more profitable and, ultimately, safer for patients. The AASC will also provide insight, feedback and “in the field” leadership for AmSpa.

Make no mistake: if medical aethetics, as an industry, doesn’t come together and support a unified approach to compliance, the industry will ultimately cease to exist. Prosecutions will go up. Investment will go down. The bad PR will increase, and patients will lose confidence. More stringent regulation will result, and the 10 Basic Rules, which are reasonable and easily implemented, will be replaced with additional regulations that make it virtually impossible for the medical aesthetic industry to exist and be profitable.