National Quality Forum
staff members now admit, after weeks of intense scrutiny, they probably didn't have strong-enough evidence to justify a recommendation that U.S. hospitals use one specific company's product over competitors. A committee of experts has been assembled to find out for sure.
The NQF, which publishes broadly influential patient-safety
recommendations for Medicare and healthcare providers, is releasing a report Friday (PDF)
detailing its response to allegations that a former co-chairman in the organization received kickbacks to influence the recommendations.
In addition to auditing the 2010 Safe Practices Report
, the report says the board has strengthened its conflicts-of-interest policies for board members, imposed new rules limiting who can serve on committees that write recommendation, and stopped accepting financial support from for-profit companies for endorsement projects.
Regarding the controversial surgical antiseptic recommendation in the 2010 report, NQF staff members have re-examined the safe practices report and concluded that the NQF probably should change the guideline.
The decision isn't yet final, however. The change to the central-line sterilization guideline and other changes to the 2010 report will be analyzed by an independent, nine-member expert committee and put out for public comment on March 31, before the report is changed. The committee will include doctors who have been critical of how the report was written, including Dr. Robert Wachter, chief of hospital medicine at UCSF Medical Center in San Francisco, and Dr. Patrick Romano, a professor at UC Davis Health System in central California.
As written, the report tells hospitals and surgeons to use a specific formulation of antiseptic sold only by a company called CareFusion to sterilize central lines. The formula combines isopropyl alcohol and a chemical called chlorhexidine.
“While it's not dangerous and it is in CDC guidelines, there is not evidence that it is any better than anything else,” NQF President and CEO Dr. Christine Cassel
said in an interview. The Centers for Disease Control and Prevention says
a chlorhexidine wash is one way to prevent a central line from becoming infected.
A Jan. 30 statement
from CareFusion maintains that the chlorhexidine formula is a “superior” agent to prepare skin before surgery, based on “a large body of evidence ... that has been published, peer reviewed and recognized by some of the best scientific minds in the world.”
But not everyone at the company felt that way. Cynthia Kirk, a former vice president of regulatory affairs at CareFusion, alleged in a whistle-blower lawsuit that the company inappropriately sponsored and influenced a scientific paper
that endorsed chlorhexidine treatments over other surgical antiseptics.
It was CareFusion's $40 million settlement of that lawsuit—without any admission of wrong-doing—that led the Justice Department to reveal that CareFusion's former parent company had given $11.6 million to a for-profit company controlled by Dr. Charles Denham in 2008. Denham co-chaired NQF safe practices committees in 2006, 2009 and 2010.
In addition, Denham's not-for-profit foundation, the Texas Medical Institute of Technology in Austin, provided $200,000 in support of the committee's work and write draft rules, according to its public tax returns. That arrangement was cut off by the NQF after publication of the 2010 report.
Although the Justice Department has called the CareFusion payments “kickbacks,” Denham denies that and has not been charged with anything.
Members of the 2010 committee have told Modern Healthcare
in interviews that they were uncomfortable with the way Denham steered the committee toward the chlorhexidine formula—which initially appeared in two recommendations, but was finalized in only one.
“Leadership was uncomfortable with Dr. Denham and his sort of pushiness with this particular product and severed relationships at that time,” Cassel said. “The discomfort people had at that time was because of this question about the quality of the evidence about this one product. But the issue of the kickbacks was not known at the time.”Follow Joe Carlson on Twitter: @MHJCarlson