States Lax in Regulating Cosmetic Surgery

Journal of Medicine - Only 21 states require the accreditation or licensing of offices where doctors perform surgery. Offices that are accredited or licensed must have certain life-saving emergency equipment and drugs, adhere to strict safety procedures in areas including recordkeeping, anesthesia and cleanliness and be subject to inspection.

The 21 States requiring accreditation and/or licensure are: Washington, Oregon, Nevada, California, Arizona, Colorado, Kansas, Texas, Louisiana, Florida, South Carolina, Tennessee, Kentucky, Indiana, Ohio, Pennsylvania, New York, Connecticut, Rhode Island, New Jersey and Virginia.

Three patients of a former Phoenix emergency room doctor died after having cosmetic surgery at his offices. That helped persuade the Arizona board of medicine to publish guidelines in early 2008 about the kind of training doctors practicing outside of their specialties need to be competent in the procedures they do. The doctor, Peter Normann, was convicted of two counts of second-degree murder and one count of manslaughter and sentenced to 25 years in prison in September. He is appealing the conviction.

North Carolina's medical board indefinitely suspended the license of ear, nose and throat surgeon Paul Drago's license based on complaints from women who received "substandard" cosmetic surgery procedures and other evidence he was unfit to practice, according to the board's consent order. The board also temporarily suspended the license of a general practitioner doing cosmetic surgery after becoming concerned about his cosmetic practice and finding evidence he operated on family members and prescribed drugs to himself.

The two cases influenced the board's decision in March to adopt a position statement that says doctors who expand their practices will be held to the same standards as more extensively trained physicians and must ensure they have enough education and training.

States are starting to address the growing issue of what some call "practice drift" — physicians working outside of the areas in which they're trained and board certified. In addition to Arizona and North Carolina, at least nine other states spell out in statutes that doctors have to be competent in any procedures they perform.

"This is on the radar of many state boards," says Humayun Chaudhry, a physician and CEO of the Federation of State Medical Boards (FSMB). "What doctors should or shouldn't do when they change their area of focus is a concern for everyone."

As cosmetic surgery surges in popularity and insurance payouts to doctors decline, the temptation for physicians to branch into new, potentially risky procedures has never been greater, regulators, doctors and plaintiff lawyers say. Insurance companies and hospitals typically prohibit doctors from practicing outside of their specialties, but office surgery facilities are unregulated in more than half of states. As interest in cosmetic procedures spreads outside of urban areas and coastal states, there are sweeping differences in state laws governing what kinds of surgeries doctors can perform and where.

"There are so many areas of medicine that are considered to be lucrative, that it's attracted physicians to do those procedures who really aren't trained to do them," says Jim Leventhal, a Denver plaintiff attorney who chairs the American Association for Justice's professional negligence section. "Laws need to be passed which regulate outpatient procedures requiring appropriate training to perform the procedure and appropriate training and equipment to respond immediately should a patient need emergency care."

Some physicians are expanding into cosmetic surgery from unrelated practices, such as in obstetrics or radiology. Clinics that employ board-certified plastic surgeons have also been accused of downplaying the risks and aggressively marketing cheap alternatives to traditional plastic surgery. The series reported on some of the deaths and injuries — especially from liposuction — that have resulted from this commoditization of cosmetic surgery.

Earlier this month, the Florida Senate's health regulation committee unanimously approved a bill that would require spas that provide beauty treatments and liposuction to comply with existing laws and safety rules that govern other surgery centers. Committee Vice Chair Eleanor Sobel, a Democrat, said her bill "fixes a problem that allowed facilities to avoid safety protections and inspections by declining to offer anesthesia and instead using pills or injections."

Practice drift into cosmetic surgery may be more pervasive, but it's just one of "the problems in medicine whereby doctors — or non-doctors — are doing things they don't have the training and experience to do," says trauma and cancer surgeon James Hinsdale, immediate past president of the California Medical Association. He says doctors with hospital privileges to perform certain procedures will branch into others, such as laproscopic procedures, once in the operating room.

Only 21 states require licensing and/or accreditation of offices where surgery is performed. "With cosmetic surgery, procedures are almost always done in the office, often without necessary and appropriate arrangements for emergencies," North Carolina medical board spokeswoman Jean Fisher-Brinkley says of the national problem. "Doctors who drift typically do not have hospital privileges to do the procedures they are doing in the office (so) if complications do arise, the doctor often cannot even accompany the patient to the hospital."

Without strong state laws, the courts become the regulator, says Kansas City, Mo., plaintiff lawyer Dan DeFeo. Until states have greater uniformity in laws, physicians will just move to where there's a demand and less oversight, he says.

Arizona's practice guidelines listed cosmetic surgery, pain management and erectile dysfunction as the most common areas attracting non-specialists.

Daniel Brookoff was an oncologist before he started practicing pain management in Denver. According to a lawsuit filed on her behalf, furniture chain owner Leslie Fishbein was treated for back pain by Brookoff and died of a heart attack after 30 injections of the powerful anesthetic Marcaine. The lawsuit charged the facility didn't have adequate emergency equipment, staff or medications and that Brookoff was negligent.

Attorney Leventhal brought five cases against Brookoff and clinic owner HCA, including the lawsuit on behalf of Fishbein's widower, Sam. After two of his patients died and three others suffered brain injuries, Brookoff committed suicide in April.

Brookoff's attorneys confirmed the Leventhal lawsuits were settled out of court. In a response filed to Fishbein's lawsuit before settlement, lawyers for Brookoff and HCA denied the allegations.

More than 50 patients claimed in a multi-plaintiff lawsuit that North Carolina ENT doctor Drago misrepresented his background, failed to use sterile equipment, let people who weren't doctors perform liposuction and was negligent in surgery and anesthesia. A response filed by Drago's attorneys said he met the "applicable standards of care."

The case was settled out of court. Drago lost his license to practice medicine in North Carolina, but he is now a doctor in South Carolina's state prison system.

State boards of medicine can discipline doctors who are doing procedures they aren't qualified or trained to do or who are putting patients at risk in an unsafe office surgery facility. These practices can fall under sweeping prohibitions against unprofessional conduct or "substandard care," says Lisa Robins, FSMB's chief advocacy officer.

David Henderson, executive director of the North Carolina Board of Medicine, says violation of the board's position statement "could constitute unprofessional conduct." Still, while it's time-consuming to get a law passed, it would likely expedite the disciplinary process. "Instead of bringing experts in to testify what the standards of practice or unprofessional conduct are, we could simply introduce into evidence a copy of the law," Henderson says.

But Scott Kirby, a doctor and medical director of the North Carolina board, says a law restricting practice drift could stifle doctors' abilities to innovate. He says the board more closely scrutinizes substandard care allegations about doctors practicing outside of their specialties.

Dermatologists Brett Coldiron and John Starling have been fueling the fight against laws requiring accreditation of office-based surgery, which they say is costly and could restrict care for patients. They say data on Florida and Alabama's surgical complications show plastic surgeons — who are required to work in accredited facilities by their membership boards — have far more complications than other doctors performing cosmetic surgery. Starling acknowledges, there is no data on how many procedures are done, by plastic surgeons or surgeons in general.

If a state doesn't have formal guidance or a law covering office-based surgery and the doctors who practice it, "more people are going to get injured," says Sidney Wolfe, a medical doctor and director of Public Citizen's Health Research Group. "States should want to expand their existing authority."

Many state boards have adopted statutes, rules, policies and/or guidelines for the regulation of office-based surgery. According to the Federation of State Medical Boards, these changes focus on increasing safety during procedures by means including having enough trained personnel and "adequate malpractice insurance."

Among state legislative and regulatory efforts:

New York. Bill would require that every facility operating as an office-based surgery practice or setting to have a certificate of registration along with a full accreditation.

Tennessee. Bill would require all cosmetic outpatient surgery clinics to be licensed and regulated by the state health department.

Florida. Would require doctors who perform office surgical liposuction and remove more than 1,000 cubic centimeters of supernatant fat to register with the Department of Health.

Alabama. Recently amended office-based surgery rules to require registration for doctors performing office-based tumescent liposuction procedures and procedures using propofol.

Washington. Final rules in January govern osteopathic physicians who perform surgical procedures and use anesthesia, analgesia or sedation in offices.

Copyright 2012- National College of Physicians (NCNP.ORG)-All Rights Reserved

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