To summarize the events up to our last post on the subject:
- The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
- The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
- The Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
- The implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
- The draft of the standard to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
- The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor
- NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs, established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.
- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure
- In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.
- Senator Charles Grassley is now investigating
- Dr Christine Cassel, the CEO of the NQF, who had previous been the CEO of the American Board of Internal Medicine, was reported to be on the boards of directors of Kaiser Permanente Health Plans and Hospitals, a large non-profit health maintenance organization and hospital system, and Premier Inc, a for-profit hospital group purchasing organization. Both these organizations could be affected by the standards set by the NQF, and possibly by the certification standards set by the ABIM.
A Change in Course at NQF
At the time these conflicts were disclosed by ProPublica, , an NQF spokesperson and the NQF board chairperson suggested that the organization was well aware of these relationships, did not believe they were serious conflicts of interest, but chose to manage them by having Dr Cassel recuse herself from specific activities that could be construed as conflicts of interest. ProPublica quoted ethics experts who suggested that nearly all of Cr Cassel's activities at NQF could be involved in such conflicts, and hence such management would be inadequate.
Less than two weeks later, reports appeared that Dr Cassel will be resigning from the boards of Kaiser and Premier Inc. As reported by Joe Carlson writing in Modern Healthcare,
In continuing fallout from a recent conflict-of-interest scandal, National Quality Forum President and CEO Dr Christine Cassel is stepping down from two outside board of directors jobs amid questions about whether they created conflicts of interest for her.
Cassel, 68, has worked on the board of directors at Kaiser Permanente Health Plane and Hospitals since 2003, and has held board jobs with healthcare supplier and consultant Premier and its predecessors since 2008. She told the National Quality Forum board of directors on Wednesday that she is resigning both roles because they had become a 'distraction' for the NQF.
The story was also reported by ProPublica, and briefly with focus on California-based Kaiser, by the Los Angeles Times and the San Francisco Business Times.
But the resignations were just to reduce "distraction," as per ProPublica,
The Quality Forum said in a statement today that Cassel's decision to sever ties was voluntary.
'Although serving on these boards provided her with direct knowledge of many current issues in health care, as well as practices of good governance, the issue of her board involvement had become a distraction,' the organization said in a prepared statement.
[NQF board of trustees chair Helen] Darling said she believed it was an asset to have Cassel aligned with such prominent organizations like Kaiser and Premier. 'It’s like saying you’ve got a Ph.D. from Harvard,' Darling said. 'This is something you’d be proud of.'
Ms Darling did not explain how the issue had become so distracting as to lead to a disavowal of something of which one should be so proud.
Modern Healthcare also reported that the National Quality Forum will re-review the 2010 standards that recommended use of a CareFusion product and were written by a committee that included Dr Denham, who was alleged by the US Department of Justice to have taken kickbacks from CareFusion.
What About the American Board of Internal Medicine?
Before coming to the NQF in 2013, Dr Cassel was the president and CEO of the American Board of Internal Medicine (per the NQF press release announcing her appointment). In our last post on the subject, I raised the question of whether Dr Cassel could have had a conflict of interest related to her stewardship over Premier Inc while she was running the ABIM. However, at the time of the last post, there was nothing public about whether Dr Cassel had a role with Premier Inc or its predecessor organizations while she was the leader of the ABIM. .
Now, according to Joe Carlson writing in Modern Healthcare, it seems that Dr Cassel had been on the board of the privately held but for profit predecessor of the publicly traded Premier Inc since 2008, overlapping at least five years of her leadership of ABIM. Per that article, "Premier arranges for the purchases of products that could be affected by the NQF's patient-safety recommendations," and per the ProPublica article, Premier has an interest in what influences "practices adopted by medical providers across the country." As we wrote previously, the ABIM has a very substantial influence on health care. Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc. Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress. So it would appear that Dr Cassel's long term stewardship of the predecessor of Premier Inc could have been just as important a conflict of interest for her as ABIM CEO as it appears to be for her as NQF CEO.
This case increasingly demonstrates how pervasive is the web of conflicts of interest that is now draped over all of health care. It also shows how important health care organizations seem to be lead by an overlapping, interconnected group of insiders. The same names appear again and again amidst the top hierarchies. The more ingrown the leadership of health care becomes, the more isolated it may be from the realities of health care for patients and health care professionals on the ground.
Specifically re the extension of this case to the American Board of Internal Medicine, to update what I wrote previously, in my humble opinion the current ABIM leadership needs to consider that Dr Cassel, its previous long-term CEO, had a conflict of interest involving her membership of the board of the private for-profit predecessor to Premier Inc from 2008 to 2013. Was this conflict disclosed to the ABIM board of trustees? If so, was there an attempt at management, and why was it not publicly disclosed? If the conflict was not disclosed to anyone, why not? If what was done conforms to current ABIM policies on conflicts of interest, should these policies be strengthened? If what was done did not conform to such policies, should their enforcement be strengthened?
To repeat, Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.] To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.