Florida’s tough new safety rule for medical-office surgery, years in the making, has been delayed at the last minute by an outcry from obstetrician-gynecologists.
The OB-Gyns appeared Friday at the Florida Board of Medicine, which was to have passed the safety rule that day, to ask for an amendment to spare them from some of the provisions. Board members decided instead to postpone the issue while they figure out what to do.
The delay throws a monkey wrench into the joint adoption of the rule by the Board of Medicine and Board of Osteopathic Medicine. In fact, the latter board already passed it in the form that the OB-Gyns protested.
The physicians protesting the move say it would force them to stop doing certain common procedures in an ordinary medical office, which the rule calls “Level One.” They would have to add staff and equipment to become “Level Two” offices, which they claim would boost the cost of the procedures beyond many women's ability to pay.
"We're concerned that the rule is actually going to prevent access and not assure safety," said OB-Gyn Aaron Elkin of Hollywood. "We applaud the Board of Medicine for creating this rule," but it needs amending, he said.
The amendment, put forward by Bradenton OB-Gyn Aaron Sudbury, would allow OB-Gyns to provide certain medications for pain prior to and during office procedures that other doctors could not. If the OB-Gyns get their wish, members of the board predicted, it will open the floodgates to other specialties that want a "carve-out."
Prominent anesthesiologists who have spent the past couple of years helping the boards draft and hold hearings on the rule were exasperated by the OB-Gyns' last-minute interference.
"No one wants to restrict anyone's access to care," said Dr. Jay Epstein of Tampa, immediate past president of the Florida Society of Anesthesiologists. "But we can't provide access to care in an unsafe manner."
Fellow anesthesiologist Dr. Steven Woodring, an osteopathic physician in Naples, said the Society of Anesthesiologists "is very committed to these patients getting the highest quality access to care that they can. We will support whatever efforts that will attain that goal in a safe manner. Getting access to care in an unsafe environment does not accomplish anything."
The anesthesiologists were particularly unhappy with the Florida Medical Association's decision to back the OB-Gyns. Representatives of the three groups exchanged testy remarks in the hallway after the board hearing.
Epstein said he thinks that FMA's concern was triggered by the idea that the regulation infringed on doctors' independence.
"We've got to find a way...to achieve patient safety goals while still looking out for important things like access to care and autonomy for physicians," he said.
The objectors cast the issue as an infringement on women's right to affordable care for no good reason, given that in-office gynecology has an impressive safety record, they said.
OB-Gyn Dr. Karen Harris, medical director for patient safety and quality for Florida Womencare, said that her statewide practice based in Gainesville has collected data on thousands of in-office procedures and found serious complications in less than one-half of 1 percent. And patient satisfaction surveys show women prefer going to the doctor’s office to a surgery center or hospital.
"We're saving the health care system money, providing better outcomes for patients, improving patient satisfaction -- it really is a homerun," she said.
One of the procedures Harris highlighted that would no longer be able to be done in an ordinary medical office is a popular permanent form of birth control, the insertion of tiny coil implants to block the Fallopian tubes. She called it by the name of the best-known type of implant, Essure (ee-sure), but the procedure’s medical name is hysteroscopic sterilization.
Studies have found that this type of sterilization is less expensive than tubal ligation -- more than $1,000 less, as an a National Institutes of Health article reported. The research says it carries less risk because there is no incision.
But doing it without any medication (except an anti-anxiety drug such as Valium) as the rule requires would be inappropriate, Harris said. The procedure triggers cramps, which are not only unpleasant for the patient but can make the implants difficult to place.
The types and amounts of pain medication depend on the patient, Harris said. Patient information websites say they usually include substantial doses of NSAIDs (non-steroidal anti-inflammatory drugs), in pill form before the procedure and as an injection or IV at the office. Also, an opiate such as Vicodin is sometimes given before the procedure.
Harris said other procedures that would likely be less available in an office setting and more expensive under the rule as written include "D&C" (dilation of the cervix and scraping of the uterine lining) and “LEEP” (removal of precancerous cells from the cervix with a low-voltage wire loop).
--Health News Florida special correspondent Carol Gentry is part of WUSF Public Media in Tampa. Contact Gentry at email@example.com. Health News Florida receives support from the Corporation for Public Broadcasting.