The National Quality Forum
, which develops national standards for healthcare under an exclusive contract with Medicare, says it detected troubling signs that its guideline-setting process was vulnerable to industry corruption long before the U.S. Justice Department came calling.
The NQF has been cooperating with federal investigators since 2012, but it took steps as early as 2010 to revamp its conflict-of-interest policies and sever ties with Dr. Charles Denham, a renowned patient-safety expert and journal editor who this month was accused of accepting $11.6 million in kickbacks to influence the group's guidelines.
Denham served as co-chairman of the NQF's Safe Practices Committee from 2006 to 2010. In an expanded public statement Wednesday
, the organization noted that its peer-review process ferreted out irregularities before the publication of a specific recommendation in the 2010 update to its expanded safe practice guidelines.
As drafted by the committee that Denham co-chaired, Safe Practice 22 recommended that surgeons use an alcohol-based preparation sold by CareFusion called ChloraPrep to kill skin bacteria before surgeries. However, that recommendation was stricken before publication in part because Denham's “inordinate” interest in it raised suspicions among other patient-safety experts, and the evidence showing ChloraPrep was better than similar products on the market wasn't conclusive.
This week Dr. Denham confirmed, in a statement from his attorney, that CareFusion paid him $11.6 million in 2008.
Denham said the money was for two legitimate contracts between CareFusion and his company, Health Care Concepts, but the Justice Department says CareFusion paid the money to influence Denham's work at the National Quality Forum.
In legal filings, federal attorneys accused Denham of using the contracts to conceal the fact that the money was actually intended to buy influence. The contracts, the government alleged, were supposed to pay for consulting work, strategic marketing and software development, but in fact the prices were inflated far beyond fair-market value and the terms of the agreements weren't enforced anyway.
Those allegations became public through a $40 million settlement agreement
that CareFusion officials signed this month with the Justice Department to resolve allegations of off-label marketing of ChloraPrep. A former CareFusion executive accused the company in a whistle-blower lawsuit of marketing ChloraPrep for uses not approved by the Food and Drug Administration. The company did not admit wrongdoing in the settlement.
CareFusion also sells an array of medical devices and supplies, as well as software and analytics to support safety and quality goals such as infection prevention and medication management.
Even though the settlement explicitly outlines the allegations against Denham, he was not mentioned in the whistle-blower lawsuit. Denham has not been charged with a crime or sued for allegedly taking the CareFusion kickbacks. His attorney said Denham has cooperated with investigators on the case and will continue to do so.
The National Quality Forum cut ties with Denham in March 2010, even going so far as to cancel a contract under which Denham's foundation, the Texas Medical Institute of Technology, had been due to pay the NQF “to support the work of two projects and an academic paper,” the forum's statement says.
The incident caused the NQF to revamp its conflict-of-interest policies in 2010 and 2013, including the addition of a policy that it would not accept grants from people on guideline-writing committees.
The organization also reviewed all of Denham's work at the NQF and found no other evidence of untoward influence.
The NQF already required that its recommendations be publicly vetted and voted upon, and that critics have a chance to call for an “ad hoc” review of reports prior to publication, as happened with Safe Practice 22.
“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,” the NQF statement says.Follow Joe Carlson on Twitter: @MHJCarlson