By Ruth Carol, contributing writer, September 01, 2014
As the appetite of American consumers for minimally invasive cosmetic procedures continues to grow, so do the dermatologists’ patient safety concerns for those procedures performed in medical spas by unqualified physicians or non-physicians. They are turning largely to legislative and regulatory efforts and have met with some success, but ultimately, advocates said, dermatologists have to take their message to the public at large.
Medical spas, also known as medispas or med spas for short, offer a range of services, including medical and surgical procedures to improve one’s well-being and/or appearance in a non-traditional setting. Common medical aesthetic procedures performed at medical spas include laser hair removal, intense pulsed light (IPL) and other laser treatments, microdermabrasion, chemical peels, and filler and botulinum toxin injections. Some offer body contouring and even liposuction. These services are often provided by physicians or non-physicians who may have limited or no formal training or education in aesthetic medicine. The latter may be operating with limited or no supervision by a licensed and/or qualified physician.
In 2012, the spa industry generated a record high $14 billion in revenue and employed more than 343,000 individuals in the United States, according to the International SPA Association. The total number of spa visits reached 160 million, returning to its pre-recession peak. Determining how many medical spas there are is difficult because they are largely unregulated, but estimates suggest there are 2,000-plus in this country. In 2013, 13.4 million cosmetic minimally invasive procedures were performed, up three percent from the previous year, according to the American Society of Plastic Surgeons. The top five procedures remain the same: botulinum toxins, soft tissue fillers, chemical peels, laser hair removal, and microdermabrasion.
Patient safety concerns
“Patient safety is our prime concern,” said Kelley Pagliai Redbord, MD, chair of the American Academy of Dermatology Association’s State Policy Committee. “Dermatologists were trained to do these procedures. We’re aware of the risks and know how to treat side effects and respond to adverse events.”
Complications from minimally invasive cosmetic procedures include prolonged erythema, blistering, crusting, burns, hyperpigmentation, and infection. Permanent scarring and pigmentation loss are common adverse events. In 2012, a group A Streptococcus outbreak at medical spas in Maryland and Delaware resulted in four confirmed and nine suspected cases; one of the hospitalized patients died. Poor infection control practices were cited as the likely cause of the infection affecting the 13 individuals who had undergone liposuction. In addition to issues like that one, individuals lacking proper training or supervision may laser what they think is a brown spot, but is actually a melanoma, Dr. Redbord said.
Growing evidence demonstrates that bad outcomes are occurring more frequently as the cosmetic industry is growing and more of these procedures are being done by non-physicians, noted Bruce Brod, MD, a dermatologist in Lancaster, Pennsylvania. The number of lawsuits filed against non-physicians — including registered nurses (RNs), nurse practitioners (NPs), and aestheticians or technicians — performing cutaneous laser surgery has more than doubled in recent years, according to a study published in the April 2014 issue of JAMA Dermatology (JAMA Dermatol. 2014;150(4):407-411. doi:10.1001/jamadermatol.2013.7117). From 2008 to 2011, the percentage of laser-related cases that involved a procedure by a non-physician, largely involving laser hair removal, jumped from 36 percent to nearly 78 percent. The authors noted that while only one-third of laser hair removal procedures are performed by non-physicians, they accounted for nearly 76 percent of all lawsuits involving the procedure from 2004 to 2012. At the same time, the medical spa setting has been an increasing focus of litigation; from 1999 to 2012 64 percent of cases involving non-physicians involved a spa, with the figure rising to nearly 77 percent from 2008 to 2012. (Cases involving non-physicians in a physician office fell from a third of cases in the full time period to 23.4 percent from 2008 to 2012.)[pagebreak]
Commercialization of medical procedures
The proliferation of medical spas has lulled the public into thinking that these are safe places in which to have these procedures done. “Cosmetic dermatology is not easy, but we’ve made it look easy,” said Tina S. Alster, MD, director of the Washington Institute of Dermatologic Laser Surgery in D.C. “Laser and other devices have become so ubiquitous that the public is led to believe that they are safe.” But using lasers requires a lot of training and knowledge, such as knowing what type to use, how much energy to use on different skin types and different parts of the body, and who are good candidates and who are not. People go to medical spas because they are conveniently located, often in a nearby mall, and they can get a walk-in appointment. “At the end of the day, these people are practicing medicine without a license,” Dr. Alster noted.
Plus the price points are good at medical spas. “They bundle services, so if the price of one visit is x, 10 visits may be 3 x,” said Jeffrey Dover, MD, co-director of SkinCare Physicians in Chestnut Hill, Massachusetts. “In general, medical spas are a relatively low quality, low price, high-volume business with moderate to low qualified individuals providing the services. They make it seem like these procedures are so simple. These places are nicely decorated, the people are friendly, and the price is right.”
Sometimes consumers may be misled into thinking that they are getting the same quality of service at a medical spa as they would if a dermatologist was providing the same service in his or her office, he added. Many of the procedures being performed at medical spas are relatively straightforward when done in a dermatologist’s office. But that’s because dermatologists are more skilled and have years or training and education when it comes to these procedures, Dr. Dover said, so that even if the same procedures are performed by a non-physician in the physician’s office, the dermatologist is on-site and can prevent a catastrophic outcome from occurring. This could explain why the JAMA Dermatology authors found fewer cases set in physician offices than in spas.
Consumers are misled when medical directors are not forthcoming about their training, noted Amy Derick, MD, a Barrington, Illinois-based dermatologist. Some medical directors market themselves as a board-certified physician, but they won’t say in what. “The average person will think that a board-certified physician specializing in dermatology is a board-certified dermatologist, but that’s not always the case,” she said. Dr. Derick advocates for full disclosure regarding the education and training of the medical director as well as the individuals performing the procedures.
Truth in advertising
Full disclosure to the public regarding the physician’s or non-physician’s credentials falls under the purview of truth-in-advertising (TIA) legislation. While 14 states have enacted such legislation, unfortunately it doesn’t always apply to medical spas, Dr. Brod explained. That’s because procedures provided in medical spas are considered medical aesthetic procedures and not the practice of medicine in many states.
“There is strong evidence that the public wants to know who is performing these procedures,” Dr. Brod said. “There is also evidence to suggest that the public doesn’t understand the level of training required by the various licensed or unlicensed professionals working in medical spas.”
Of the legislative approaches taken by the American Academy of Dermatology Association (AADA), TIA has proven to be the most successful. This year, the Tennessee General Assembly passed the Tennessee Patient Safety Cosmetic Procedures Act, which defines medical spas and cosmetic procedures, and requires supervising physicians to disclose whether or not they are licensed in the state and list their board certification or lack thereof. It must be a board recognized by the American Board of Medical Specialties or American Osteopathic Association or one approved by the state medical board.[pagebreak]
The Tennessee Dermatology Society and the Tennessee Medical and Surgical Laser Society lobbied hard to have specific language incorporated into the bill, said Michael Zanolli, MD, a Nashville dermatologist involved in the regulation of the practice of medicine in Tennessee. The Tennessee State Board of Medical Examiners has not defined any rules regarding the legislation nor was it required by the legislature to do so. Dr. Zanolli thinks it is primarily because the issue crosses professional lines and the cosmetologists and nurses registered in the state, especially the advanced practice registered nurses, and other physician groups are all stakeholders in medical spas and constituents of the state legislators. However, a special report from the state medical examiners board submitted to the state legislature last session helped outline important general principles if and/or when the legislature discusses regulation of medical spas again.
In Pennsylvania, where Dr. Brod practices, a TIA bill using the AADA’s model language is currently in committee. He is hopeful that it will become law in the next legislative session despite it being an election year, which can make getting anything passed more difficult. The state already has a law requiring health care professionals to wear identification badges, but it doesn’t apply to medical spas.
Scope of practice
Scope of practice regulation revolves around who can perform medical aesthetic procedures and in what setting. State medical boards, which regulate the practice of medicine, have authority over physicians and physician assistants (PAs) working in medical spas, but it doesn’t extend to the nurses and aestheticians, which are employed by many medical spas.
A recent survey of state medical boards shows just how much their regulation of minimally invasive cosmetic procedures varies. Currently, all minimally invasive cosmetic procedures can be delegated to at least one type of non-physician at the physician’s discretion, according to a survey of 31 allopathic medical boards published in the January 2012 issue of the Journal of the American Academy of Dermatology (J Am Acad Dermatol 2012;66:86-91). But state medical boards have limited ability to regulate non-physicians. An equal number of boards require general supervision of non-physicians or some type of on-site supervision; a small number permitted off-site supervision. Few states require reporting of incidents involving these procedures, something that the AADA encourages, Dr. Redbord said.
Regulating medical aesthetic procedures requires legislation, which is always more challenging than getting regulation passed, Dr. Brod said. Last year, Connecticut did pass a bill that requires a physician medical director of a medical spa to meet certain criteria. Moreover, the medical director must perform an initial physical assessment of a person before he or she can undergo a cosmetic medical procedure. Procedures may be performed by a physician, PA, advanced practice registered nurse, or RN. However, in the case of the non-physicians, they must be working under physician supervision. The bill also requires medical spas to post the medical director’s name and specialty in a public area and use them in all advertisements. The bill does not specify a penalty for failing to comply with these requirements. Still, the Connecticut law is considered a step forward because it incorporates stricter regulations in terms of requiring a physician medical director and a physician to perform the initial assessment, Dr. Redbord noted.
Working against the AADA’s efforts is the trend of expanding the scope of practice for non-physicians that has the support of legislators and regulators as a way to increase access to medical care. “While some non-physicians may be using their expanded scope of practice to offer care in rural areas, we are seeing many use it to perform cosmetic procedures,” Dr. Brod said. The Academy has met with some success in slowing down the unfettered expansion of scope of practice by non-physicians, but it must continue to address this issue, he said. He also noted that the AADA continues acquiring data to refute the argument that expanded scope of practice is necessary to fulfil an unmet need in health care in underserved and rural areas.
Corporate practice of medicine
A handful of states ban the corporate practice of medicine, that is, state regulation or law prohibits a corporation from employing a physician to practice medicine. The concern of these laws is that the corporation not have undue influence over the physicians’ independent medical judgment. Similarly, the Academy “opposes any corporate practices or other policies that would compromise a patient’s well-being by superseding a licensed physician’s clinical decision-making.”
The danger of corporate ownership is that it creates misaligned incentives, Dr. Brod noted. “The corporation is geared to making a profit and not adhering to best practices of medicine and patient safety, which may put undue pressure on physicians and other health care providers working there,” he said. For this reason some states have robust corporate practice of medicine rules to assure the public that the physician owns the practice and dictates the care of the patient as opposed to a non-physician business entity. Hospitals which employ physicians are typically exempt from these rules.[pagebreak]
In 2012, California passed a law that called for a more severe penalty for engaging in the corporate practice of medicine. Violating the law is a felony that comes with a $50,000 fine. This law helps prevent a non-physician entity, such as a laser franchise, from opening a medical spa — or at least force them to think twice about it, Dr. Brod added.
Using all three approaches — truth in advertising, scope of practice, and corporate practice of medicine — enables the Academy to tailor its efforts in a certain state at a particular time. “They all address the issue, but in different ways,” said Lawrence Green, MD, a Rockville, Maryland-based dermatologist who is also vice chair of SkinPAC. In California, corporate practice of medicine was used to address a big problem with medical spas lacking physician involvement. In Maryland, people were being harmed by individuals performing minimally invasive cosmetic procedures so the state medical board stepped in to further regulate them. Of the handful of states that currently address the performance of medical aesthetic services or medical spas, Maryland stands out as having the most comprehensive regulations, including training requirements for both supervising physicians and non-physician providers and language requiring immediate physician availability. This legislation passed in 2010 after four years of efforts, noted Dr. Green, who worked with the state medical society on their passage.
Taking years to get legislation passed is only one of the challenges that seem to be mounting. Another challenge is that legislators are often looking at this issue from a small business perspective and not as a patient safety concern. They are reluctant to take it on because of push back from the medical spa owners in their districts, Dr. Brod said. Another challenge is that recently passed laws allow NPs and PAs to work in a medical clinic unsupervised and see new patients. “That makes it harder to carve out a requirement for a physician to be on-site in a medical spa,” he added. Another challenge is to get the house of medicine aligned on this issue. Right now, not all specialists share the dermatologists’ point of view regarding, for example, the need for a physician medical director, on-site supervision of all non-physician personnel, licensure and inspection of the facility to ensure sanitary standards are being maintained, and having procedures in place to address emergencies/complications. Truth in advertising has been so successful because most specialists can agree on that, whereas there isn’t unanimous agreement about sweeping regulation of medical spas, he added.
The experts agree that it is imperative that dermatologists continue their battle to ensure that medical spas offer medical aesthetic services provided by qualified, appropriately credentialed and trained physicians and supervised non-physicians to ensure that patient safety and quality of care is not jeopardized. “Where we see a problem is lack of oversight, education, knowledge, and judgment,” Dr. Dover said. “If one of those is missing, there’s a potential problem. If all four of those are missing, you’re really asking for trouble.” But they must also take their message to the public. It behooves all dermatologists to educate their patients about the dangers of having non-physicians with limited or no formal training or education in aesthetic medicine and who may be operating with limited or no supervision by a licensed and qualified physician perform these procedures, Dr. Green said. “They need to understand that the reason they are called medical spas is because medical-based procedures are being done there.” If dermatologists win in the public opinion arena, he said, they will win the war.