An
influential senator is demanding copies of contracts and conflict-of-interest
policies from the National Quality Forum after allegations that kickbacks were
paid to influence its patient safety guidelines.

Sen.
Charles Grassley cited “serious concerns” about how the Quality Forum vets its
expert advisers and suggested the group may have endorsed a drug for a use the
government hasn’t approved.

“This
case calls into question NQF’s due diligence and its obligation to prevent
conflicts of interest or recommendations that violate officially approved
uses,” Grassley, R-Iowa, said
in a letter to Dr. Christine Cassel, president of the nonprofit group,
whose guidelines are widely adopted by health care providers.

The
kickback allegations became public last month as the U.S. Department of Justice
settled an outstanding whistleblower lawsuit against CareFusion,
maker of a surgical antiseptic called ChloraPrep.

According to the
government, a company run by Dr. Chuck Denham, a well-known patient safety
advocate, accepted $11.6 million in contracts from CareFusion
and its former parent company. Payments to Denham were meant to sway the
Quality Forum’s endorsements, the Justice Department said. Denham has denied
taking kickbacks and said the contracts were for legitimate work.

The Quality Forum said it cut ties with
Denham in 2010 and that the undisclosed money from CareFusion
did not result in the panel recommending ChloraPrep.

But
ProPublica reported
last week that Denham recommended ChloraPrep’s
unique formulation at a Safe Practices committee meeting he co-chaired, and
that the formula was endorsed for infection prevention in one of the Quality
Forum’s final 2010 Safe Practices guidelines.

Grassley’s letter cited the ProPublica
story, which also said that a nonprofit run by Denham made $725,000 in
donations to the Quality Forum as part of a five-year contract. The group has declined
to make the contract public.

“It is
unclear what the terms of the contract were,” Grassley wrote in requesting a
copy, along with “all records related to Dr. Denham’s relationship with CareFusion.”

As the
senior member of the Senate Committee on Finance, Grassley has long been
influential in federal health care issues. The committee has oversight
responsibility for Medicaid, Medicare and other government health programs that
spend hundreds of billions annually.

In 2012, three-fourths of the Quality
Forum’s $26 million in income came from the government to endorse health care
quality measures and evaluate spending. It’s expected to receive about $10
million from the federal government this year under provisions of the
Affordable Care Act.

Spokeswoman
Ann Greiner said the Quality Forum will promptly reply to Grassley. The group already
had announced a new, 30-day review of its guidelines and policies after
ProPublica raised questions about ChloraPrep last
month.

“As
you know, we fully cooperated with the DOJ inquiry, and have our own review of
NQF processes (including conflict of interest policies) related to the 2010
Safe Practices report under way,” Greiner said in an email, referring to the
group’s latest patient safety guidelines.

The
Quality Forum was unaware of financial ties between Denham and the maker of ChloraPrep while he co-chaired the group’s Safe Practices
panel in 2009, Greiner has said.

In his
letter, Grassley appeared skeptical.

“It is
surprising that, given NQF’s close involvement with Dr. Denham and his
nonprofit, NQF says it was unaware of his connections with CareFusion,”
he wrote.

The transcript
of a committee meeting reviewed by ProPublica shows that Denham advocated on
two occasions for endorsing the same antiseptic formulation used in ChloraPrep, although he didn’t name the drug.

  
According to the Justice Department, ChloraPrep
was being marketed for uses that were not medically acceptable or approved by
the Food and Drug Administration.

ChloraPrep’s label says it is approved to “help reduce
bacteria,” but that is different than the drugmaker’s
claims that it reduced infections, according
to court papers in the case.CareFusion settled with
the government for $40 million without admitting wrongdoing.

Grassley said in his letter that he was concerned that a Quality Forum expert would
encourage non-approved uses of a drug. He also asked the Quality Forum how it
verifies information that experts like Denham provide about financial ties; whether
their disclosures are public; and how it vets contractors.

Grassley requested a response from the
Quality Forum by Feb. 18.