Dermatology World October 2011 SUPPLEMENT : Page 12
HOW SAFE? GrowinG market The growing global market for medical aesthetic procedures is forecast to reach approximately $4 billion in 2017. In 2010, 11.6 million minimally invasive procedures were performed, according to the American Society of Plastic Surgeons. The top five involve the use of botulinum toxins, soft tissue fillers, chemical peels, laser hair removal, and microdermabrasion. The current market is fueling the proliferation of medical spas. In 2007, there were 976 medical spas in the United States, according to the International SPA Association, but other estimates put that number as high as 2,500. And while annual revenues decreased slightly for the spa industry between 2005 and 2006, the association claims that revenues for medical spas more than doubled to one billion-plus during that same time. Licensing medical spas would create the appropriate funding needed to enforce regulations. Tami Cassis, M.D., a dermatologist in Prospect, Ky., who serves on the state medical licensure board, is working to present a bill that will do just that. The legislation will not only require medical spas to be licensed facilities, but will address physician supervision, including training, competency, and delegation. The goal is to present the bill during the 2011-2012 legislative session. scope of practice The focus of regulatory efforts is to establish scope of practice standards regarding who can perform medical aesthetic procedures and in what setting. Dr. Brod believes that it is the responsibility of dermatologists, as the skin care experts, to develop these standards. Such standards should include training and education requirements of both physicians and non-physicians performing services, written treatment plans and procedure protocols, and reporting of adverse events. “Right now, there’s a wide range of individuals who are not physicians and who have little or no formal training offering these medical procedures at medical spas,” Dr. Brod stated. 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 recent survey of 31 allopathic medical boards across the country published in the Journal of the American Academy of Dermatology . But medical boards have limited ability to regulate non-physicians. An equal number of boards required general supervision of non-physicians or some type of on-site supervision; a small number permitted off-site supervision. Few states required reporting of incidents involving these procedures. Western states tended to have liberal delegation and supervision requirements whereas Southern states had more stringent requirements. Certain procedures can be done by trained and licensed individuals, such as aestheticians in Tennessee who require at least one year of training, Dr. Zanolli said. “I think it is okay for them to do superficial chemical peels or laser hair removal with a low energy laser.” But there are procedures that shouldn’t be performed in medical spas or by non-physicians, he added. VaryinG state reGulations Only a handful of states currently address the performance of medical aesthetic services or medical spas. For example, Maryland has the most comprehensive regulations, which took four years to get passed in August 2010, said Rockville, Md., dermatologist Lawrence Green, M.D., who worked with the state medical society on their passage. “The longer you wait, the more difficult it is to make changes because the current practice becomes the standard practice in the state,” said Dr. Green, who became involved after seeing a growing number of patients unnecessarily injured as a result of having procedures at medispas. “I’m just one of 250 dermatologists in the D.C. area,” he said. “If I was seeing one to two patients a month with complications, so were other dermatologists.” “Many states are beginning to explore how to potentially regulate or legislate what goes on in a medical spa,” Dr. Brod said. State medical boards regulate the practice of medicine. But before that can happen, enabling legislation has to be passed giving the board the authority to do so, he explained. Because the definition of the practice of medicine varies across state lines, medical aesthetic procedures are not considered the practice of medicine in many states, noted Michael Zanolli, M.D., a dermatologist in Nashville, Tenn. He was involved in getting the Tennessee Medical Association to pass a resolution this past March to include the “enhancement of the aesthetic appearance of another” in the definition. “That’s the missing piece we needed to have a basic foundation for saying that many of these activities that occur in medical spas are indeed the practice of medicine,” he said. The resolution, which was sponsored by the Tennessee Dermatology Society, will be on the agenda for the 2011-2012 legislative session. Laser hair removal is not considered the practice of medicine in Virginia, but it is in neighboring Maryland, noted Dr. Green. “If you’re a physician assistant performing laser hair removal in Maryland, the physician has to be on-site and you have to be licensed and properly trained. If no doctor is there, the Board of Physicians can cite you for practicing medicine without a license and your licensing board can reprimand you.” Like many dermatologists, Dr. Brod would like to see the medical spas themselves regulated. “These facilities are different than ambulatory surgery centers and medical offices and, as such, should have separate licenses to operate,” he said. physician superVision Many dermatologists also take issue with physician supervision, or lack thereof, at medical spas. Most state regulations don’t define the role of medical director. When they do, physician supervision runs the gamut from direct, on-site supervision to being within a specified distance, such as 30 minutes away, in case problems arise, to off-site supervision. “Many medispas have physicians who aren’t dermatologists or plastic surgeons with little or no training supervising others. They take a one-day course to learn how to do the procedures and even then, they usually just delegate them,” Dr. Green said. The medical director could be any physician with a state license who may visit the medical spa once a week or once a month, and may live 300 miles away, said Dr. Zanolli, adding, “I’m not naïve enough to think just because a physician performs a procedure that there won’t be any side effects, www.aad.org 12 supplement to Dermatology WorlD // October 2011
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