Poor antibiotic stewardship and increasing resistance have contributed to ballooning C. diff rates, even as hospitals have made significant progress in fighting other types of healthcare-associated infections. In a March 2012 report, the Centers for Disease Control and Prevention said rates of C. diff had grown to “historically high” levels and were linked to 14,000 deaths annually.
Boca Raton (Fla.) Regional Hospital began performing fecal transplants on patients with severe C. diff in the last quarter of 2012 and has done six or seven transplants so far, said Dr. Charles Posternack, chief medical officer at the 394-bed hospital. “The procedure makes such scientific sense: C. diff grows because we kill off the normal flora, so let's put it back,” he said. “It's a simple concept, but the trouble is in operationalizing it.”
Boca Raton Regional Hospital requires that patients have their own donor who undergoes a number of screenings for hepatitis A, B and C, HIV and other diseases and pathogens. Once the donated sample is obtained, it's homogenized in a blender and inserted via colonoscopy, Posternack said.
The colonoscopy and some of the initial tests can be billed to insurance companies, but for uninsured patients who have the procedure done at Boca Raton, the total bill is about $3,000. That pales in comparison to the medical bills of many patients with recurrent C. diff, who face long hospital stays and even stints in the intensive-care unit, Posternack contends.
On Jan. 16, the New England Journal of Medicine published the results of the first-ever randomized controlled trial looking specifically at fecal transplant as a treatment for C. diff. Led by a group of researchers from the Netherlands, the study found a far higher success rate for fecal transplant through nasogastric tube than for treatment with vancomycin, a powerful antibiotic often used to treat the infection. The results were so striking that the trial was halted because of concerns that it was unethical to prevent patients in the control group from receiving fecal transplants.
“That study will definitely trigger a lot of inquiries,” said Dr. Robert Orenstein, an infectious disease specialist at the 244-bed Mayo Clinic Hospital, Phoenix.
Orenstein and a few of his colleagues began doing fecal transplants in early 2011, after a patient with a severe, recurrent case of C. diff begged for the procedure. “We were in awe of the results,” he said. “The patient was near death and was probably going to have to have most of his colon removed. Twenty-four hours later, he was walking out of the hospital.”
Galvanized by that first case, they began working out the details of a long-term program. Like Boca Raton Regional Hospital, the Mayo Clinic Hospital relies on colonoscopies, covered by insurers, to administer the donated samples. The hospital bills the donor about $1,000 for the screenings that aren't covered, and then bills the patient about $600 for the cost of processing the stool.
Like many who perform the procedure, Orenstein predicts it won't be long until insurers begin reimbursing directly for fecal transplants, especially now that promising data from a randomized trial is available. “It is so effective, it makes you wonder why we do anything else,” he said, adding that the hospital has done between 35 and 40 transplants. Still, he acknowledged that evidence-based guidelines for donor selection, infection control, handling and administration are sorely needed. Such guidelines are likely to be clearer after future trials, he said.
In the meantime, providers are designing widely varying approaches to performing the procedure. At 301-bed Meriter Hospital, Madison, Wis., Dr. Gary Griglione, the gastroenterology division chief, has performed 33 fecal transplants since launching Meriter's program less than a year ago. But unlike many other physicians who perform the procedure, he uses enemas instead of colonoscopies, a decision he says saves money without sacrificing effectiveness. “If we don't get patients cured with an enema, which costs $1.99, then we do a colonoscopy,” said Griglione, who's been performing fecal transplants for more than 25 years.
Meriter charges donors roughly $1,300 for lab tests, most of which is covered by insurers, he said. Patients pay a $140 fee for processing the sample, plus a $60 office-visit fee. “I lose money, the hospital loses money, but look what the patient saves,” Griglione said.
Dr. Colleen Kelly, a clinical assistant professor of medicine at Brown University's Alpert Medical School and a leader in the field of fecal transplantation, said the next crossroads will be regulatory. The U.S. Food and Drug Administration has expressed an interest in overseeing the procedure and ensuring it's done safely, said Kelly, who is leading another randomized trial of fecal transplantation. She fears government oversight will include “overly burdensome regulations.”
Another obstacle is one of perception, said Dr. Clifford McDonald, a medical epidemiologist and C. diff expert at the CDC. He worries the “eww” factor could hinder the progress of a promising treatment that he says could prove effective for treating other drug-resistant organisms. One solution? A name change. The term “fecal transplant” places too much emphasis on the donated material, he says. A new term—his suggestions include “intestinal microbiota restoration”—could help people to better accept the procedure.
“We need to get over the fact that these good bacteria live in our bodies and are necessary,” McDonald said.