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Health Quality Group Rethinks Drug Endorsement

The National Quality Forum says it is considering “substantive changes” to guidelines that recommend a surgical antiseptic at the center of a kickback scandal.

Modifying its previous stance, the National Quality Forum is considering whether to drop its endorsement of a surgical antiseptic that was at the center of kickback allegations in January.

The nonprofit Quality Forum said today that the option is among several steps it is taking to guard against conflicts of interest in its process for recommending patient safety measures.

The group’s endorsements are used by Medicare and throughout the health care industry. But on Jan. 9, the U.S. Justice Department alleged that a company run by Dr. Chuck Denham, a prominent patient safety advocate, had received $11.6 million in kickbacks from the company that made the antiseptic.

At the same time, Denham served as co-chairman of the Quality Forum’s safe practices committee. Transcripts show that Denham had advocated for endorsing the unique formula used in the company’s antiseptic, called ChloraPrep, as the Quality Forum developed its safe practices guidelines. 

On Jan. 22, the Quality Forum released a statement saying its safe practices guidelines did not include any reference to ChloraPrep. That turned out to be incorrect. A subsequent review by ProPublica found that the 2010 guidelines did endorse the drug’s formulation to prevent infections from central lines, the tubes that are used to make transfusions.

In its statement today, the Quality Forum said it now is considering “substantive changes” to the 2010 safe patient guidelines, including the recommendation on central-line infections, “to reflect updated guidelines and evidence.”

“The staff paid particular attention to any safe practice that included the compound in question per the Denham case,” the statement says.

The Quality Forum has said it severed ties with Denham in 2010. The allegations concerning contracts to Denham’s company, Health Care Concepts, became public when the Justice Department settled a whistleblower lawsuit involving marketing claims by CareFusion, the company that makes ChloraPrep.

Denham has denied taking kickbacks and said the $11.6 million he received from CareFusion was for legitimate contract work. He also runs the nonprofit Texas Medical Institute of Technology, which focuses on quality of care.

Quality Forum officials declined ProPublica’s interview requests. But the group’s chief executive, Dr. Christine Cassel, told the trade publication Modern Healthcare her staff found that “there is not evidence that (ChloraPrep) is any better than anything else” at preventing central-line infections.

On Thursday, Cassel said she would resign from the boards of two large health care companies that were paying her hundreds of thousands of dollars a year. Ethics experts said the outside relationships presented a conflict because the companies have financial interests in Quality Forum endorsements.

In its statement Friday, the group said it had updated its conflict-of-interest policy for board members and would also review policies governing sponsors, such as health care companies, that donate to the organization. Over several years, Denham's nonprofit had contributed $725,000 to the Quality Forum.

In addition, a committee of experts is auditing the 2010 safe practices guidelines, which are currently in effect, and make recommendations that will be available for public comment by March 31.

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