Patient Safety Orgs Cut Ties With Denham

Patient safety advocate Charles Denham, MD, denies taking kickbacks from a product manufacturer, but the National Quality Forum and the Leapfrog Group are parting ways with him.

Patient safety organizations have been rushing to review and strengthen their conflict of interest policies in the wake of federal accusations that Charles Denham, MD, with whom many had a close working relationship, received an $11.6 million kickback to persuade hospitals to purchase ChloraPrep, a commercial surgical skin sterilizer.

Denham denies the allegations.

In the last few days, at least three organizations have taken steps to distance themselves from Denham and his organizations, Health Care Concepts, CareFusion, and the Texas Medical Institute of Technology (TMIT). They are also working to bolster their conflict of interest policies.

See Also: NQF Distances Itself From Safe Practices Co-Chair

The issue arose this month when the Department of Justice announced a settlement agreement in which CareFusion, the maker of ChloraPrep will pay $40.1 million to settle claims that it provided kickbacks to market and improperly promoted the product.

In the settlement, the Department of Justice claimed that CareFusion paid Denham the kickbacks "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" while he was co-chair of the Safe Practices Committee of the National Quality Forum, "which reviews, endorses and recommends standardized healthcare performance measures and practices."

The NQF receives millions a year for this purpose under contracts with the Centers for Medicare & Medicaid Services.

The National Quality Forum
The NQF has received at least $6.5 million and up to $19.9 million between 2010 and 2013 through contracts from the Centers for Medicare & Medicaid Services to develop quality measures that may be used by health plans, Medicare, Medicaid, and other payers to reward and compare quality of care. Denham was a co-chair of NQF's Safe Practices Committee until March of 2010.

The NQF's, Safe Practice committee, which Denham is accused of trying to influence, has asked Denham to remove references from the TMIT website saying that the NQF endorsed the use of its product, ChloraPrep.

The NQF is launching "a more thorough review" of all of its 34 safe practices," and by Feb. 25, we're going to be very specific about what we found, what we're doing. We're doing all we can to understand what happened," says NQF spokeswoman Ann Greiner.

The NQF has already made the questions on its conflict of interest disclosure questionnaire "much more specific, and less open-ended," Greiner says.

"We do our work in the public interest, and really work hard to honor that," Greiner says. "The last few weeks have been very difficult…prompting us to review and assess and make sure that the policies that we currently have in place are very strong and that they help insure the integrity of what we do."

The Leapfrog Group
The Leapfrog Group, which represents employers and other large purchasers of healthcare services and health plans, has tried to improve quality of care through comparative measures. It publishes hospital safety scores that grade hospitals based on their track record for patient safety.

Denham was appointed to Leapfrog's Safe Practices Committee as Chairman in 2006. "The position represented a voluntary commitment with no financial or contractual relationship between Dr. Denham and Leapfrog," says a Leapfrog statement.

On Wednesday, Denham resigned his position from the committee "to make sure the present distraction does not impact you or the work you do." The group accepted his resignation on Thursday.

Leapfrog's president and CEO, Leah Binder, said in an interview with HealthLeaders Media: "We've never taken any money from him and we have no contracts with him."

Leapfrog has asked Denham and his company, TMIT, to "remove any language from its website implying Leapfrog endorsement of 'test beds,' as this is not authorized. Further have TMIT remove any reference to a Leapfrog Hospital Survey 'flight simulator,' as this authorization was only given in 2006 and expired in 2007."

On Thursday, Binder issued a statement saying her board "was concerned with Dr. Denham's failure to reveal to the National Quality Forum or Leapfrog his potentially compromising relationship with CareFusion, which demonstrated a lack of transparency inconsistent with our organization's core values and mission."

Leapfrog also has "formally requested" that the "NQF perform a thorough scientific review of its full slate of endorsed safe practices," initiated an organization-wide update to its conflict of interest disclosures, even updating the latest update done last month.