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NQF Distances Itself From Safe Practices Co-Chair

 |  By cclark@healthleadersmedia.com  
   January 23, 2014

While an influential advocate for patient safety and former committee chair of the National Quality Forum denies allegations that he took kickbacks from a product manufacturer, the DOJ has named him in a settlement agreement. The NQF cut ties with him years ago and updated its conflict of interest policies.

For more than a decade, the name Charles Denham, MD, has been an icon in the patient safety movement. His reputation as a technology innovator searching for solutions to reduce healthcare harms was unscathed.

Denham is editor-in-chief of the Journal of Patient Safety. He's chairman of the Leapfrog Group Safe Practices Program, co-founder of the Global Patient Safety Forum, and a producer of documentaries such as "Chasing Zero, Winning the War on Healthcare Harm," with Dennis Quaid.


See Also: Patient Safety Orgs Cut Ties With Denham


And in 2006, Denham also became the influential co-chair of the Safe Practices Committee of the National Quality Forum, which receives tens of millions of dollars in federal funds to review and endorse quality measures it believes the healthcare industry should follow to improve quality and receive full reimbursement for patient care.

In this powerful role, however, Denham appears to have gotten himself into big trouble. He allegedly used his stature and clout to promote and recommend a surgical disinfectant in exchange for millions of dollars in kickbacks from the product's manufacturer, CareFusion Corp.

Documents released by the Department of Justice over the last few days have smashed Denham's reputation to smithereens.

A Product Recommendation
A federal settlement agreement detailed by the Department of Justice on Jan. 9, links Denham with an accusation that he took $11.6 million from CareFusion, the maker of ChloraPrep, as a kickback for using his NQF position to promulgate what NQF labeled its "Safe Practices No. 22."

That Safe Practices advisory urged hospitals to buy CareFusion's ChloraPrep compound to prevent surgical site infections even though there was no evidence that the solution, chlorhexidine gluconate 2% and isopropyl alcohol, was the best skin disinfectant available.

In a statement his spokesman emailed me Wednesday, Denham maintained that the government's allegations "are blatantly false"

False or not, the NQF is now clearly embarrassed by the matter. It has issued a statement clarifying its dealings with Denham, including a clear message that it wants nothing more to do with him.

"As this [draft recommendation] was being promulgated to hospitals across the country, we got an inquiry from 3M [a competitor to CareFusion in the surgical disinfectant market] that raised concerns," Ann Greiner, the NQF's vice president of external affairs told me Wednesday.

The NQF formed an ad hoc review committee, which found that the evidence just wasn't there to recommend the ingredients in ChloraPrep as part of Safe Practice #22.

The NQF released a March, 2010 letter from 3M that said studies never evaluated whether its similar product, DuraPrep, was a better surgical site disinfectant than ChloraPrep, although another study said that it was. "3M believes that these studies suggest the need for additional clinical study before the NQF Safe Practices can recommend one prep over another," The letter stated.

Indeed, the original committee had considered a study in the January New England Journal of Medicine which found that ChloraPrep "is superior to cleansing with povidine-iodine for preventing surgical-site infection." The committee discounted the findings, however, because the study was funded by ChloraPrep's corporate parent, Cardinal Health.

The committee concluded: "Given the lack of clear evidence in support of one skin preparation over another and the experts' agreement, it is recommended that this specification be deleted from Safe Practice 22: 'Preoperatively, use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation, and allow appropriate drying time per product guidelines.'"

NQF Staff Felt Uncomfortable
It was during this process, Greiner recalls, that relations between the NQF and Denham became strained. "When this Safe Practice was going through ad hoc review, he (Denham) was very interested, and there was something about that that made the staff feel uncomfortable. He was just very interested in this particular Safe Practice, which was one of 34, and he wanted to be on the ad hoc committee."

She adds, "You know, when a committee says this needs to be further examined, and one of the chairs says he wants to be involved, and we say, 'No, I don't think so,' and he's still very interested in it," it raised suspicions.

"[So] we took steps to change our relationship with him," Greiner says.

From that point on, she says, Denham "did not work on any of our committees."

Greiner says that at no time did Denham inform the NQF of his relationship with the maker of ChloraPrep.

According to an NQF statement released late Wednesday, the NQF not only severed its relationship with Denham in March of 2010, but it declined further financial support from Denham's foundation, the non-profit Texas Medical Institute of Technology, which had given the NQF $725,000 between 2006 and 2010 for special projects. In addition, the NQF

  • Now refuses to enter grant agreements where a funder is on an endorsement committee, even as a non-voting member
  • Has reviewed other committee reports that Denham was involved in to be certain that he did not influence their outcomes, and
  • Has updated its conflict of interest policy

Denham: Reports Are 'Blatantly False'
I tried to reach Denham directly to hear his side of the story, but instead received an e-mailed statement from his spokesman. It says allegations that CareFusion paid $11.6 million in improper kickbacks to Denham while he was NQF Safe Practices Committee co-chair "are blatantly false reports."

"The qui tam complaint involved in the settlement between the government and CareFusion makes absolutely no mention of Dr. Denham, and does not involve him or any of his companies in any way. The (whistleblower) action revolved around CareFusion's alleged off-label promotion of one of its products."

Rather, it is the executed settlement agreement, which HealthLeaders Media obtained Wednesday from the Department of Justice, that details the accusations against Denham.

It says that CareFusion, which had spun off of Cardinal Health, has agreed to pay $40.1 million to settle a Department of Justice false claims lawsuit, which dealt in part with the accusations against Denham. The agreement also says that CareFusion promoted products for uses "that were not medically accepted indications, and made unsubstantiated representations about the appropriate uses of ChloraPrep."

Red Flags
In 2008, Cardinal Health agreed to pay Denham's HCC $9.1 million for certain software development, strategic marketing, and consulting services and $2.5 million for the completion of three enumerated projects, the DOJ settlement says.

"The United States contends that the compensation for the underlying services in these agreements was not fair market value, the terms of the deliverables in the agreements were not enforced consistent with their terms, and one purpose of these agreements was to conceal kickbacks to Dr. Charles Denham, the owner and operator of HCC…

 

…The United States contends that CareFusion's payments to HCC were made for the purpose of influencing Dr. Denham's work as co-chair of the Safe Practices Committee and for the purpose of inducing Dr. Denham to recommend, promote and/or arrange for the purchase of CareFusion's product, ChloraPrep, in violation of the Federal Anti-Kickback statute."

Greiner emphasizes that at NQF, the system worked. Red flags went up in 2010, two years before federal officials contacted NQF about the whistleblower lawsuit.

"Clearly all of what we do, whether they are endorsed measures or recommended safe practices, will have higher stakes as we move into pay for reporting and pay for payment," Greiner says.

"It's important to remember that we do have these processes in place multiple reviews, open meetings, public comments and this ad hoc process—to safeguard our integrity."

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