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.
