State boards keep an eye on medical spas

Some state medical boards are scrambling to regulate services at medical spas across the country to ensure that patients are safe and that physicians perform or supervise certain procedures properly.

Boards are taking action as the number of spas continues to grow. There are more than 1,000 in the United States, offering services such as laser hair removal, chemical peels, Botox injections and microdermabrasion in resort-like settings. Typically, a physician or other licensed health care professional has an ownership interest, is on staff or provides supervision at the spa, board officials said.

Thus far, many boards have approached oversight piecemeal, responding to complaints from patients or physicians on a particular procedure and creating rules on it. One major problem is that different practitioners -- such as aestheticians, cosmetologists and nurses -- do various procedures, and each is regulated by a different board in most states.

But as the number of spas increases, board officials say they are boosting their efforts to keep up with the pace. Massachusetts, for example, has formed a medical spa task force to draft standards and regulations, attracting attention from other boards interested to see what it proposes.

"There is a need because this is a growing area of interest for the consumer, and we have to protect the public," said task force Chair Nancy Achin Audesse, executive director of the Massachusetts Board of Registration in Medicine. "There is a huge gap in oversight, and it's a huge opportunity for us to make a difference in patient protection."

The Federation of State Medical Boards has no national guidelines on how boards should deal with medical spas. But the organization is raising awareness about the facilities. The FSMB in October devoted its monthly roundtable conference call to medical spas, and 40 boards participated. Last month, a board attorneys' workshop featured a session about spas.

"It is something that's being looked at around the country because it's a relatively new phenomenon and it's changing very rapidly. We're monitoring what states are doing and sharing information at this point," said Lisa Robin, FSMB senior vice president of member services.

Making clear what's allowed

Boards have been examining issues such as what role physicians play, what services are provided and what policies are needed. Florida and California, for example, have regulations on Botox injections and laser hair removal. In the past decade, many state boards have enacted rules on use of laser devices, spelling out the participation or supervision of physicians.

In 2004, the North Carolina Medical Board investigated complaints against several spas and decided to revise its position statement on laser surgery, which includes laser hair removal, said Thomas Mansfield, director of the board's legal department. Then a college student died in January 2005, days after she applied an anesthetic gel to her legs to prepare for laser hair removal.

"Certainly, the tragic death of that young woman increased the board's motivation" to revise the laser rules, Mansfield said.

In July 2005, the board approved a revised statement that said each laser hair removal patient must first be examined by a physician, a physician assistant or a nurse practitioner. A physician is expected to provide adequate oversight before and after the procedure, the board said.

The board later reprimanded the medical director of the spa where the student had planned to have the procedure, and the director agreed not to supervise any laser hair removal in the state. This August, state legislators passed a law that requires physician supervision of anyone doing laser hair removal.

The Kansas State Board of Healing Arts adopted its laser regulations in 2001 and recently has turned its attention to another cosmetic procedure -- lipodissolve, the injection of a compound to dissolve fat. The medical board this summer adopted a rule saying physicians could not administer or authorize the use of phosphatidylcholine, sodium deoxycholate or any combination of the two substances for injections, except in clinical research.

But a medical spa company took the matter to court, saying adequate public hearings were not held on the new rule. In September, a district court judge agreed and sent the matter back to the board for additional hearings.

Mark Stafford, general counsel of the Kansas board, said it's a challenge to keep up with new services provided at spas and other facilities.

"About the time we get out hands around this one, something else will come along," he said.

While boards adopt new rules, medical spas are trying to decipher what it all means to them.

"Medical boards are looking at [spas] very closely now. The problem with the boards is they change their rules and regulations and don't let anyone know," said Hannelore Leavy, founder and executive director of the International Medical Spa Assn. in New Jersey.

Leavy said boards need to open a dialogue with spas to let them know about rules being adopted.

In Massachusetts, regulators are hoping to clarify the picture. Last year, state legislators passed a law that created the medical spa task force. The group is looking at oversight and regulations that may be needed for spas in the state, and it expects to make recommendations to lawmakers this month or in January 2008.

"There was a lot of murkiness about what the rules are," said Audesse, the task force chair. "There will be a significant legislative proposal that will create appropriate oversight and guidelines for medical spas."