Hospitals wanting to delve into new areas of surgical specialty should face tougher scrutiny before being allowed to launch a new program, some health quality and policy leaders say.
As the U.S. healthcare landscape advances toward rewarding quality rather than quantity, just buying a new high-tech surgical tool or hiring skilled surgeons may not be enough to support offering the new service. Facilities should more frequently be asked to prove not only the ability to achieve good clinical outcomes, but that there is a community demand for the service in the first place, they say.
In an environment where facilities aim to maximize revenue and where they get paid from third-party reimbursements, the launch of new surgical programs could result from all the wrong reasons, says Devon Herrick, senior fellow at the National Center for Health Policy Analysis, a Dallas, Texas-based think-tank.
“They don't establish them because they have a competitive advantage or are especially skilled in the area,” he says. But rather, “because there are patients who have insurance that will reimburse for these lucrative services.” If hospitals don't compete on price, they probably don't compete on quality either, he said.
The recent case of St. Mary's Medical Center in West Palm Beach, Fla., which suspended elective pediatric congenital heart surgeries last week amid claims of high death rates, is renewing focus on the problem.
The facility began operating on pediatric heart patients in 2011 following approval by the state's Agency for Healthcare Administration. Florida is one of about 15 states with laws requiring a Certificate of Need before a facility can expand, offer a new service or purchase certain pieces of equipment. Though the state has been advancing plans to remove such controversial legislation according to local reports.
“No other hospital in Florida has received such approval in more than 15 years,” the hospital touted in September of 2011. Congenital heart defects are fairly common and locals now can access the “very unique minimally invasive treatment option right here in the local community,” the statement said.
According to the Centers for Disease Control, however, the heart defects affect nearly 1% (about 40,000) births per year in the United States and about 25% of those babies are critical enough to require surgery. Over the past four years, St. Mary's has done only 132 separate heart procedures on a total of 90 patients.
That's led some to question whether there was indeed a demand for the hospital to provide the service in that community. Families and insurers could have sent patients to already established facilities that have specialized pediatric cardiovascular care teams and in some cases average more than 800 of the procedures each year.
“Ask a parent if they would prefer a place that does that many, or one that does one every other week. I don't think it takes a genius to figure that out,” says Dr. Edward Bove, who heads the divisions of pediatric and adult cardiac surgery at the University of Michigan Health System. He also collaborates with Joe DiMaggio Children's Hospital, where a handful of the patients from St. Mary's had to been transferred for additional care.
Programs handling only small volumes of work may not be current on advances, and may be unable to innovate and improve the field of work, Bove said. He and others contend that volume matters, and because many of the pediatric heart surgeries are elective, the patients should be transferred to places that already do large volumes and have robust teams.
In fact studies have shown that high-volume hospitals not only have better outcomes, but that they also have lower costs. A 2013 study in the Journal of the American College of Cardiology found of 12,718 operations done at 27 hospitals, the median costs increased with operation complexity. For example, the median cost for an arterial switch was $129,229 and the median priced for a procedure known as Norwood was $238,959. High-volume centers generally had lower costs for the most complex procedures.
Some say, in places like Florida, where hospitals require a Certificate of Need (CON) before a new service can be offered, it should be required to prove the resources will be available to adequately establish a program and that the facility will be able to meet volumes needed to remain proficient.
Several of these concerns were raised during public hearings in 2009 for St. Mary's CON process, as noted in documents provided by the Florida Agency for Health Care Administration. At the time, St. Mary's open heart surgery program was expected to generate 64 cases in the first year and 66 cases in the second—already a low volume, but still higher than the 46 and 44 the hospital actually achieved.
“Reduced volumes at existing facilities would impact quality and lead to worse outcomes,” said an attorney representing another area children's hospital during the 2009 hearing. Another speaker noted that the formula for determining volume “might be used as a guideline, but is not accurate.” If the methodology were applied to the 239,000 births statewide in 2007, there should be six programs in the state with about 100 cases, the speaker said. “But the state has eight programs that on average are doing about 161 cases.”
Dr. Richard Perryman, chief of cardiac surgical services for Memorial Healthcare System, which operates the Joe DiMaggio Children's Hospital Heart Institute, argued that because these types of pediatric heart cases are not emergent there was no reason “to dilute the experience of existing pediatric cardiac surgery programs by the creation of another as yet inexperienced, untested and yet to be formed.”
Cardiac surgeons who spoke to Modern Healthcare also pointed to the need to provide specialized cardiac teams around the clock. “You really need an entire city of people, it's an enormous technical undertaking,” Bove says. “You don't just go out and hire a surgeon.”
It remains unclear as to whether or not St. Mary's Medical Center has such support on staff. In documents for the certificate of need, the hospital said it would have on-call policies to enable the rapid mobilization of surgical and medical support for emergency cases. The hospital said it would specifically recruit staff with appropriate experience and training in pediatric open heart surgery, and had recognized anesthesiologists in the area and would seek contractual arrangements with perfusion providers.
Legal claims filed in 2014 by the law firm Searcy Denney Scarola Barnhart & Shipley, which is representing at least four families whose infants underwent care at St. Mary's, accused the hospital of not being able to quickly recognize and treat intra-operative and post-surgical complications, alluded to “systematic failures” and point to a lack of a team approach.
The “our team” page of the hospital's cardiothoracic surgery program, only lists Dr. Michael Black, the surgeon at the center of current media reports. However the hospital told Modern Healthcare it is “working diligently to attract and retain clinical staff with expertise in pediatric cardiovascular surgery.”
The Joint Commission which accredits U.S. hospitals and conducts unannounced onsite surveys, says the situation at St. Mary's is something it “will likely take a look at.”
The group does not evaluate what types of services are appropriate for a specific facility, but says failing to create the proper infrastructure to provide them- like not having the right equipment, staffing or ICU support- could threaten accreditation status.
That's something leadership should take into account when considering the launch of a new specialty program, says Ana Pujols-McKee, chief medical officer for the Commission. Creating the program, “Perhaps that's the easy part,” she said. Leadership commitment to zero harm, establishing a robust process of improvement and the creation of a safety culture, “That's the fundamental element,” Mckee said.
“Before you put a brick down, before you buy a piece of equipment, before you hire someone—if you don't have leadership driving the right safety culture, you really don't have a good platform to build on.”