The National Quality Forum (NQF) is grappling with the fallout of a recent settlement addressing conflict-of-interest allegations on a high-profile committee that issues quality guidelines widely regarded as the gold standard for health care.
According to the Department of Justice (DOJ), the medical technology company CareFusion agreed this month to pay $40.1 million to settle allegations that it violated the False Claims Act when it paid kickbacks and promoted products for uses that had not been approved by the FDA.
The settlement resolves allegations that the company paid $11.6 million in kickbacks to Charles Denham while he served as co-chair of NQF's Safe Practices Committee. The government argues that the purpose of those payments was to encourage Denham to recommend and promote the purchase of its ChloraPrep skin-preparation products.
Major supplier accused of trying to bribe key NQF official
ProPublica takes a closer look
According to a ProPublica investigation, the NQF committee recommended use of ChloraPrep to prevent surgical site infections in its 2009 draft guidelines, but the practice did not make the final 2010 report. The final report did call for an antiseptic with a chemical makeup similar to ChloraPrep in protocols to reduce central-line infections.
Patrick Romano of the University of California-Davis School of Medicine told ProPublica that the recommendation "is likely to reflect improper commercial influence." Both Romano and Johns Hopkins safety expert Peter Pronovost said they were uncomfortable by the "rushed" process leading up the final report. "[T]oo much work was being done by Denham's own staff," Romano said.
NQF officials say Denham never reported an issue, even when committee members were asked to disclose financial relationships in 2009. "He clearly lied," NQF President and CEO Christine Cassel told ProPublica, adding, "He just didn't say anything about any of his business relationships."
NQF takes action. Is it enough?
NQF cut ties with Denham in March 2010 and canceled a contract with his foundation, the Texas Medical Institute of Technology, which had been contributing to "the work of two projects and an academic paper," the forum said in a public statement. The group also overhauled its conflict-of-interest policies in 2010 and 2013, adding a rule against grants from individuals on guideline-writing panels.
NQF notes that it already requires that recommendations be publicly scrutinized and voted on, offering critics the opportunity to request "ad hoc" reviews of reports before publication. It was this process that ultimately prevented the publication of the guidelines with the tainted ChloraPrep recommendation, according to the group.
"While these processes add additional time to review and evaluation, they are critical to ensuring that NQF-endorsed measures/safe practices are of the highest quality, are linked to strong medical evidence, and are without bias," NQF said in a statement.
Nonetheless, experts say the situation has prompted speculation about the inner workings of the NQF and highlighted the lack of government oversight in the burgeoning quality improvement industry.
"The disclosure requirements for quality and safety are less mature than they are for a drug trial or a product trial," says Pronovost, adding, "This quality and safety effort has to be guided by the science. If it starts getting tainted by people with financial interest, it could really distort the field" (Allen, ProPublica, 1/28; Carlson, Modern Healthcare, 1/23 [subscription required]; Carlson, Modern Healthcare, 1/25 [subscription required]).
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