New rules for Botox injections 

Posted: 7:00 pm Mon, September 6, 2010
By Ben Mook
Daily Record Business Writer

Up until August, anyone looking to have years shaved off their face through the injection of Botox and wrinkle fillers, or have excess hair taken off with a laser, could not be 100 percent sure the person holding the needle or laser was a physician, or a medical professional.

Maryland did not classify these so-called low-risk cosmetic services as medical procedures, so they were unregulated. While most such services are carried out in doctors’ offices and medical spas overseen by physicians, some said they were concerned that problems could arise as more doctors and businesses started offering the procedures.

“The concern was that medicine was changing and there was very little regulation,” said Dr. Lawrence J. Green, a Rockville-based dermatologist and assistant professor of dermatology at George Washington University. “There was no such thing as some of these procedures 10 to 15 years ago.”

The Maryland Board of Physicians spent four years working with doctors across different specialties and MedChi, the Maryland State Medical Society, to come up with the regulations meant to protect the public from any possibly unsafe procedures. The regulations took effect Aug. 23.

“With these procedures, you can be injecting chemicals into your body, and the people doing it should have medical training,” MedChi CEO Gene M. Ransom III said. “It might sound like a simple thing, but it’s not. These regulations clarify who can do them, and who is qualified.”

The result are the regulations that now define these cosmetic procedures as the practice of medicine and require they be performed in most cases by a physician trained in those practices. Non-physicians in violation of these regulations can be found guilty of practicing medicine without a license and fined up to $50,000.

One of the reasons the regulations took so long to enact was that the procedures cross several medical specialties, like plastic surgery and dermatology. MedChi, which represents physicians in all specialties, did not want the regulations to be skewed to favor only certain specialties.

“Our first reaction was that it would be a fight between the different factions,” Ransom said. “But, really, the overall, general reaction was that this needed to be addressed for the safety of the patients. So, it wasn’t about one specialty trying to capture market share.”

The regulations allow all physicians to offer the procedures if they have taken applicable continuing medical education. This would be training approved by the American Medical Association.

“We don’t want to stop non-core physicians from doing these, we just want it so it’s safe for the public,” Green said.

Also, a physician now has to be on-site unless the board of physicians has approved a plan of delegation. And, in that case, physicians will be held responsible for ensuring that their health professionals, like physician’s assistants and registered nurses, have the proper training.

A doctor must also examine the patient before the first procedure or course of treatment and maintain a detailed medical record.

“We want people to know that someone in a white lab coat isn’t always a doctor, and these are medical procedures being offered,” Kerry Kalinsky, spokeswoman for the American Society for Dermatologic Surgery Association, said.