The dramatic growth of private surgery centers in Pennsylvania hit a speed bump earlier this month when the state Department of Health ruled the centers should not perform many "keyhole" or laparoscopic surgeries.
The state's order, which addressed laparoscopic gall bladder surgery but possibly other procedures, says the surgeries should be confined to hospitals because they can better handle complications. Doctors say surgery centers are very safe.
Surgery centers long have been the bane of some hospitals, which view them as competitors for some lucrative services. While that has fueled speculation of a link between hospitals and the department's order, even some hospital officials say they are at a loss to explain the decision.
In a Dec. 1 notice to surgery centers, the health department cited a September report by Peter D. Jacobson, a University of Michigan public health specialist, that outlines the risk posed by laparoscopic surgeries.
The patient safety concern prompted the department to act, state officials said.
But Jacobson said in an interview that he questions the state's decision.
"I'm very disturbed about how my work is being used here," he said. "There's nothing that I talked about dealing with whether these procedures should be conducted in a surgery center or a hospital. They've cited me on something that is not part of my report."
The growth in laparoscopic procedures, as well as the migration of patients from hospitals to surgery centers, are two of the bigger trends in health care during the past 20 years.
In laparoscopic surgery, a video camera peers into the body through a slender tube, called a laparoscope, that is inserted through a keyhole incision. Images are beamed to a television so doctors can watch as they cut, retract, stitch and remove material with tiny instruments that are passed through even smaller incisions. Laparoscopic procedures can be used for everything from hernia repairs to appendectomies.
While traditional "open" procedures require larger cuts, the smaller incisions in laparoscopic procedures are thought to reduce post-operative pain.
Surgery centers are often designed to alleviate a different sort of pain: the struggle to find a parking spot. The centers tend to be newer facilities in areas of recent development and are more convenient for some patients.
Between July 2003 and May 2004, the number of surgery centers in the state grew from 113 to 161, according to the Pennsylvania Health Care Cost Containment Council, an independent state agency. In fiscal year 2003, surgery centers in Pennsylvania had net patient revenues of $315 million, based on more than 500,000 patient visits.
While those figures represent a small fraction of the outpatient revenue and visits at the state's hospitals, the surgery centers are taking a bigger piece of the pie each year. And surgery-center operators are pocketing a bigger share of the revenue. The average total margin for acute hospitals during fiscal year 2003 was 2.3 percent, compared to nearly 16 percent at surgery centers, according to the council.
Surgery center operators say they have been performing laparoscopic procedures for years, but the state Department of Health became aware of the practice only this year, said spokesman Richard McGarvey.
State regulations prohibit surgery centers from performing operations that require major or prolonged invasion of body cavities. While laparoscopic slits are small, they still constitute an injury risk, according to the state.
"We were not trying to say that a cut was major and a scope was minor -- we think any time you enter a body cavity and are doing it on a prolonged basis, that's something serious and that's something that should be done in a hospital-based setting," said Jerry Radke of the state's bureau of facility licensure and certification.
A reading of the regulations makes it quite clear why the department acted, said Dr. Christopher J. Daly, a retired surgeon who is now an associate professor at the Rangos School of the Health Sciences at Duquesne University. But, according to Daly, that's not to say the regulations treat surgery centers fairly.
Daly started performing laparoscopic surgeries in 1989 and, by the late 1990s, had done several involving gall bladders in surgery centers. The operations generally are very safe, Daly said, but they do carry a small risk of major injury to blood vessels. Such injuries can require urgent care, including vascular surgeons and access to a blood bank -- two things that aren't always available at a surgery center, Daly said.
He noted, however, that many smaller hospitals lack these backups as well. Yet, those hospitals are not affected by the state's notice.
"I hate to take this business away from outpatient surgery centers, because when you talk about the cost of doing all this, surgery centers make a lot of sense," Daly said.
The reduced cost of doing laparoscopic procedures in surgery centers, as opposed to hospitals, is one of many arguments cited by Dr. Philip Ripepi when he talks about his opposition to the health department's decision.
Ripepi founded Southwestern Ambulatory Surgery Center in Jefferson in 1986, and his center was one of two in the state this year where regulators noted that laparoscopic surgeries where occurring. Ripepi said he questioned how this could have been surprising to the state, since the center is inspected annually and always provides a list of procedures performed.
Southwestern started doing laparoscopic gall bladder surgery in 1999, and the results of the 12 or so procedures it performs annually have been spectacular, said Dr. Antonio Ripepi, who now performs the surgeries. One key to safety is selecting patients who have low risk of complications, he said.
Don McCoy, vice president of health policy and regulatory affairs at the Pennsylvania Medical Society, cited a national survey that suggested more than 44,000 laparoscopic gall bladder procedures were performed in ambulatory surgery centers during 2003. Removing just these procedures from surgery centers would have an impact, but the medical society is particularly concerned that even more common laparoscopic procedures will be affected.
One surgery center operator in Eastern Pennsylvania, for example, said she was told by a state inspector that the center should stop performing laparoscopic tubal ligations, a gynecological procedure.
"One of the concerns is that the notice is not clear on which laparoscopic procedures you can do," McCoy said. "It implies you can do some hernia repairs, but it doesn't give you a list of those that can or can't be performed."
McGarvey, the department's spokesman, said most attempts to change regulations take about a year, while the department conducts hearings, but legislators can get involved in changing regulations, too.
Jacobson investigated the safety of laparoscopic procedures as part of a report published by the Pew Charitable Trusts' ongoing study of medical malpractice issues in Pennsylvania. He said he had seen no data to suggest the procedures are more safely performed at hospitals. "The hospitals may be using whatever means to limit the loss of income to the outpatient surgery centers," he said. "I can't see any other explanation for it."
The Hospital & Healthsystem Association of Pennsylvania had no comment on the matter, saying it was still surveying its members to understand the notice's impact. Hospitals with ownership in surgery centers, such as those in the Heritage Valley Health System, could be hurt by the department's decision. Typically, surgeons own the centers where the procedures are performed.
But Dr. Philip Caushaj, the chairman of surgery at West Penn Hospital, said hospitals have not been agitating about this issue.
"By and large, I think the Department of Health does a very good job," said Caushaj, who is president of the Pittsburgh Surgical Society. "But I wish they had talked to us about this, prior to this announcement, because I think most of us would have reassured them that carefully selected patients can easily be done at ambulatory surgical facilities."