The National Quality Forum said today that it revised its conflict of interest policies and took several steps to distance itself from Dr. Charles Denham and his organization after severing all ties with the doctor in 2010, several years before his name surfaced in a legal settlement over an alleged kickbacks scheme involving CareFusion (NYSE:CFN).
As first reported yesterday by MassDevice.com, the NQF asked Denham to step away from his role as co-chair of the Safe Practices Committee 2 years ahead of a federal probe because officials at the forum were uncomfortable with his "inordinate interest" in including CareFusion’s ChloraPrep skin wipe in national standards.
In an expanded statement released today, the NQF said it took several more steps following Denham’s removal, including discontinuing a grant agreement with his organization, the Texas Medical Institute of Technology, 3 years before it was set to expire in 2013 – TIMIT had donated a total of $725,000 between 2006 and 2010 to NQF to support academic work at the forum. NQF officials also reviewed committee reports in which Denham was involved to "be certain that he did not influence their outcome."
NQF officials further revised the forum’s conflict of interest policy in 2010 and again in 2013.
"In addition to strengthening its conflict of interest policies and its policies that govern relationships with funders, NQF made sure that it preserved its existing rigorous endorsement criteria and transparent processes, both of which are also important to the integrity of NQF’s work," the group said in a prepared release. " These policies include multiple reviews of expert committee recommendations, open meetings and public commenting on reports, NQF member voting on recommended measures/practices, and the ability to suggest to NQF an ad hoc review of a decision."
The U.S. Justice Dept., in a Jan. 9 press release announcing a $40.1 million settlement with CareFusion, charged the San Diego-based medical device company with paying out $11.6 million to induce Denham to "recommend, promote and arrange for the purchase" of ChloraPrep wipes to healthcare providers.
Denham, who has not spoken publicly about the allegations, confirmed through his attorney that his company, Health Care Concepts, received 2 contracts from CareFusion totalling $11.6 million.
Read more MassDevice.com coverage of the case
According to court filings, those contracts included a $9.1 million Master Solutions Agreement for "certain software development, strategic, marketing and consulting services" and an additional $2.5 million research agreement for "3 enumerated projects." The consulting agreements were signed in 2008, prior to the spinout of CareFusion from Cardinal Health.
At the time, Denham was co-chairman of the Safe Practices Committee at NQF, a non-profit that reviews and endorses standardized healthcare practices and performance measures for hospitals in the interest of improving patient safety under a contract with the Centers for Medicare & Medicaid Services.
In 2010, prompted by the committee Denham sat on, the NQF included in a draft release of its 2010 Safe Practices Report a recommendation that ChloraPrep be used for skin preparation prior to surgery to reduce surgical-site infections. The NQF said this week that they pulled the ChloraPrep recommendation before issuing the final report after an ad hoc review did not find sufficient evidence to support 1 skin preparation over another. The NQF said the review was spurned by concerns over Denham’s intense interest in including ChloraPrep, which ultimately led the organization to cut ties with the doctor.
"There was discomfort in [Denham’s] engagement with the process, which led us to want to sever our relationship with him in 2010," Ann Grenier, Ann Grenier, NQF’s vice president of public affairs, told MassDevice.com yesterday.
No criminal charges have been filed against Denham, who has not responded to repeated requests for comment.
