Series: Patient Safety Exploring Quality of Care in the U.S.

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.