By Scott Dance, The Baltimore Sun
3:52 PM EDT, April 27, 2013
Maryland is moving to toughen regulations on the fast-growing medspa industry — a move designed to narrow a "loophole" and prevent deaths such as one last year following a liposuction treatment at a Timonium facility.
Regulations being discussed by state officials would bar plastic surgeons from performing liposuction and other procedures in medspas and medical offices unless the facilities are inspected by the government or third-party accrediting bodies, Maryland Secretary of Health Joshua Sharfstein said.
The changes would bring greater scrutiny to an industry where patients typically pay out of pocket for procedures — making the consumer the main oversight authority, instead of private or government insurers who demand safeguards, Sharfstein said.
"The goal is to make sure the riskier procedures are happening in the safer places," he said.
Maryland is among a growing number of states seeking to regulate where liposuction and other procedures can be performed. Twenty-seven states have passed laws or imposed rules regarding where surgeries can take place, according to the American Association for Accreditation of Ambulatory Surgery Facilities.
Florida, for example, passed a law last year requiring annual inspection of any facility that removes more than 1,000 cubic centimeters of fat during liposuction. In New York, accreditation is required for any office-based surgery that removes more than 500 cubic centimeters of fat during liposuction or uses anything more than minimal anesthesia.
"A lot of states are figuring out these issues with medspas," said Dr. Doug Forman, a plastic surgeon in North Bethesda who serves on the American Society of Plastic Surgeons' government affairs committee. "Nationally, medspas are falling into this gray zone."
While there were about 800 medspas across the country five years ago, there are nearly 5,000 now registered with the International Medical Spa Association, said executive director Allan Share.
But there is no definition for what qualifies as a medspa, and they include facilities that offer a range of services from Botox to complex surgeries, Share said. The industry as growing as centers seek to capture demand from cash-paying customers, he said.
"Minimally invasive" procedures such as laser skin treatments and Botox injections have increased 6 percent since 2000, according to the plastic surgeons society. Surgical procedures, meanwhile, have declined 16 percent over the same period.
Health officials encourage patients to verify that licensed physicians are performing their cosmetic surgery procedures and that the operations are taking place in accredited facilities that are either equipped to handle emergencies or have relationships with nearby hospitals.
Doctors and other health care workers have been charged with a range of infractions in recent years, sometimes with serious results, Maryland Board of Physicians records show.
Maryland lawmakers were pressed into action last year after a Lochearn woman died of an infection contracted during liposuction at Monarch Medspa in Timonium.
But earlier cases show similar risks. A doctor at another Timonium plastic surgery center lost his medical license in 2011 after two of his patients died of complications from complex cosmetic surgeries. Officials reprimanded that doctor and others for performing procedures in inappropriate settings.
Other people have been disciplined for providing procedures such as laser hair removal without a medical license at all.
The state Department of Health and Mental Hygiene elevated plastic surgery regulation to a top legislative priority in the days after regulators shut down Monarch Medspa in September over "probable deviations from standard infection control practices." Three patients contracted aggressive infections after undergoing liposuction; one of them, 59-year-old Eula Witherspoon, died less than a week after the procedure.
Monarch officials had pledged to work with authorities and extended their sympathies when the infections came to light. They could not be reached for further comment.
At the time, Sharfstein noted "an unevenness" in regulation over liposuction and other cosmetic procedures. While the Board of Physicians licenses doctors who work in medspas or other private practices, the facilities where they work are not always subject to oversight.
The 2013 General Assembly approved a bill authorizing the health department to develop regulations that address the loophole. Health officials expect Gov. Martin O'Malley to sign the bill next month, though Raquel Guillory, a spokeswoman for the governor, said it's not clear when that will be.
The process of developing and imposing regulations could take a year, Sharfstein said.
Regulators plan to start by seeking public input on procedures that should be covered by the requirements, Sharfstein said. That could include liposuction and other surgical procedures that require anesthesia, he said.
Plastic surgeons who operate out of offices that are already accredited welcomed the new regulations as a boon to patient safety. For example, Dr. Adam Summers of the Maryland Plastic Surgery Center in Glen Burnie said that facility would not be affected by the regulations because, although the center bills itself as a "medical spa," it is already licensed by the state as an ambulatory surgical center.
Unregulated medspas are "looking to capitalize on the fact that those procedures are relatively easy and safe to do," Summers said. "The issue is, when you've got a medical spa who goes to the next level and starts offering things like liposuction, now you've got an office not set up for operational sterility and a doctor who's potentially not trained in all the nuances of liposuction."
Licensure and accreditation are not required for all medspas because government health care programs Medicare and Medicaid don't pay for cosmetic surgery, but some centers opt to pursue the certifications anyway. The new regulations being proposed by the state would target medspas that don't seek such oversight.
Plastic surgeons and health officials cautioned that any cosmetic procedure involving a scalpel or a laser involves risk, though. Board of Physicians records show a variety of disciplinary actions in recent years involving plastic surgeons and cosmetic procedures.
In one case, Dr. Oscar Ramirez was stripped of his Maryland medical license in 2011 after the deaths of two patients in 2004 and 2005 at his Timonium office, Esthetique Internationale. One of the patients, a 58-year-old woman seeking "body contouring" surgery to remove fat and tighten skin around her stomach and thighs ahead of her son's wedding, spent 101/2 hours under anesthesia for the surgery, according to Board of Physicians documents. Three days later her husband awoke to find her not breathing; her cause of death was determined to be cardiac arrhythmia.
In the other case, a 55-year-old man sought surgery to remove acne scarring and to thin out his cheeks. He spent 121/2 hours under anesthesia, and less than two hours after the surgery died of cardiac arrhythmia.
The Board of Physicians said Ramirez should not have performed the lengthy surgeries in an office setting because of the risk of complications. The facility was accredited by an industry organization, but the board said it didn't meet the accreditation standards because it wasn't inspected annually and because Ramirez lacked any relationships with nearby hospitals that would have allowed him to admit patients in the event of complications.
Ramirez could not be reached for comment, but his lawyer, M. Natalie McSherry of Kramon & Graham PA in Baltimore, said he continues to disagree with the board's decision. Ramirez argues that his care did not cause the deaths and that his facility was indeed accredited, McSherry said.
The board decision was upheld by Baltimore City Circuit Court and the Maryland Court of Special Appeals. Ramirez plans to petition the case to the Maryland Court of Appeals, McSherry said.
In other cases, the board issued cease-and-desist orders to people who were performing procedures including skin tightening and laser hair removal despite lacking medical licenses, sometimes nevertheless referring to themselves as "doctor."
Summers, the Glen Burnie surgeon, was reprimanded in 2011 because employees in his office called a physician assistant "doctor." The woman had been a doctor in Bulgaria but was not acting outside the scope of her authority as a physician assistant, Summers said.
Regulating where procedures can take place may not guarantee such problems will be prevented, but it "makes it less likely there'll be a tragedy," Sharfstein said.
He added, "Patients still need to ask a lot of questions even after we've set up this whole regimen."
Tips for patients
When choosing where to get a procedure, health officials recommend that patients:
•Verify the physician's license at the Maryland Board of Physicians website: http://www.mbp.state.md.us
•Visit the facility and ask to see recovery rooms.
•Ask if the facility is equipped to handle emergencies or has relationships with nearby hospitals.
•Ask if it is accredited by an industry association or the state.
•If you are receiving anesthesia, ask what type it is and the recovery time.
•More questions and other information can be found at mhcc.maryland.gov/consumerinfo/amsurg/checklist.htm
Sources: Maryland Department of Health and Mental Hygiene and the Maryland Ambulatory Surgery Facility Consumer Guide
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