Washington, DC - A recent Department of Justice (DOJ) settlement underscores the need for the National Quality Forum (NQF) to maintain its rigorous, objective process to ensure the integrity of quality measures and safe practices.
On Jan. 9, DOJ announced a $40.1 million settlement with CareFusion Corp., based, in part, on its relationship with a former NQF committee co-chair, Dr. Charles Denham. The settlement resolves allegations that Dr. Denham accepted $11.6 million from CareFusion to promote one of its products while he co-chaired the NQF Safe Practices Committee (2006, 2009 and 2010).
The Safe Practices Committee initially recommended endorsement of a safe practice (Safe Practice #22) that included use of a type of skin preparation prior to surgery, a preparation sold by CareFusion.
The reference to this specific type of skin preparation was removed from the draft Safe Practices report after an NQF ad hoc review did not find sufficient evidence to support one skin preparation over another. The ad hoc review effectively served its role of rapidly responding when a potential issue is identified. This structure is an important safeguard that allows information from the field to surface in order to facilitate expert review and an NQF response as appropriate.
The final NQF Safe Practices report, published in April 2010, did not include any reference to the specific skin preparation.
In addition to Dr. Denham’s involvement in NQF’s work, Dr. Denham’s foundation, TMIT, supported the work of two projects and an academic paper (a total of $725,000 between 2006 and 2010). Since March 2010, NQF has not worked with Dr. Denham or his foundation and has not received any financial support from his foundation. NQF has cooperated fully with DOJ inquiries, which began in 2012.
In response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:
- Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
- Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
- Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
- Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
- Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;
In recent years as endorsed measures and safe practices have been publicly reported and linked to payment, the stakes have risen for both providers and industry. In response, NQF has strengthened its processes to ensure their integrity.
In addition to strengthening its conflict of interest policies and its policies that govern relationships with funders, NQF made sure that it preserved its existing rigorous endorsement criteria and transparent processes, both of which are also important to the integrity of NQF’s work. These policies include multiple reviews of expert committee recommendations, open meetings and public commenting on reports, NQF member voting on recommended measures/practices, and the ability to suggest to NQF an ad hoc review of a decision.
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.